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Chemistry

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Also known as: Dexmethylphenidate hcl, Focalin, D-threo-methylphenidate hydrochloride, 19262-68-1, Focalin xr, 23655-65-4
Molecular Formula
C14H20ClNO2
Molecular Weight
269.77  g/mol
InChI Key
JUMYIBMBTDDLNG-OJERSXHUSA-N
FDA UNII
1678OK0E08

Dexmethylphenidate
A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.
1 2D Structure

Dexmethylphenidate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
methyl (2R)-2-phenyl-2-[(2R)-piperidin-2-yl]acetate;hydrochloride
2.1.2 InChI
InChI=1S/C14H19NO2.ClH/c1-17-14(16)13(11-7-3-2-4-8-11)12-9-5-6-10-15-12;/h2-4,7-8,12-13,15H,5-6,9-10H2,1H3;1H/t12-,13-;/m1./s1
2.1.3 InChI Key
JUMYIBMBTDDLNG-OJERSXHUSA-N
2.1.4 Canonical SMILES
COC(=O)C(C1CCCCN1)C2=CC=CC=C2.Cl
2.1.5 Isomeric SMILES
COC(=O)[C@@H]([C@H]1CCCCN1)C2=CC=CC=C2.Cl
2.2 Other Identifiers
2.2.1 UNII
1678OK0E08
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Dexmethylphenidate

2. Focalin

3. Focalin Xr

4. Hydrochloride, Dexmethylphenidate

5. Xr, Focalin

2.3.2 Depositor-Supplied Synonyms

1. Dexmethylphenidate Hcl

2. Focalin

3. D-threo-methylphenidate Hydrochloride

4. 19262-68-1

5. Focalin Xr

6. 23655-65-4

7. Metadate Cd

8. Metadate Er

9. Equasym Xl

10. Dexmethylphenidate Hydrochloride [usan]

11. Ritalin

12. 4b3sc438hi

13. Dex-methylphenidate Hydrochloride

14. Methyl (2r)-2-phenyl-2-[(2r)-piperidin-2-yl]acetate;hydrochloride

15. 1678ok0e08

16. Methylphenidate D-threo-form Hydrochloride

17. Methyl (2r)-phenyl((2r)-piperidin-2-yl)acetate Hydrochloride

18. 19262-68-1 (hcl)

19. Methyl (2r)-2-phenyl-2-[(2r)-piperidin-1-ium-2-yl]acetate;chloride

20. Quillichew

21. Quillivant

22. Aptensio

23. Foquest

24. Oros Mph

25. Aptensio Xr

26. Methylin Er

27. Ritalin La

28. Ritalin Sr

29. Chembl904

30. (r)-methyl 2-phenyl-2-((r)-piperidin-2-yl)acetate Hydrochloride

31. Daytrana

32. Dexmethylphenidate Hydrochloride (usan)

33. Spd544

34. Spd-544

35. Dl-threo-methylphenidate Hcl

36. Biphentin

37. Equasym

38. Methypatch

39. Metadate Mr

40. Unii-1678ok0e08

41. Equasym Ir

42. Ritalin Qd

43. Focalin (tn)

44. Dl-threo-methylphenidate Hydrochloride

45. Adhansia Xr

46. Jornay Pm

47. Methyl .alpha.-phenyl-2-piperidineacetate Hydrochloride

48. Unii-4b3sc438hi

49. Nwp-06

50. Dtxsid50940927

51. D-threo Methylphenidate Hydrochloride

52. Akos027321667

53. Rac-threo-methylphenidate Hydrochloride

54. 2-piperidineacetic Acid, Alpha-phenyl-, Methyl Ester, Hydrochloride, (alphar,2r)-

55. 2-piperidineacetic Acid, Alpha-phenyl-, Methyl Ester, Hydrochloride, (r*,r*)- (+-)-

56. 2-piperidineacetic Acid, Alpha-phenyl-, Methyl Ester, Hydrochloride, (r-(r*,r*))-

57. Methylphenidate Hydrochloride [mi]

58. (+/-)-threo-methylphenidate Hydrochloride

59. Methylphenidate Hydrochloride [jan]

60. Methylphenidate Hydrochloride [mart.]

61. Methylphenidate Hydrochloride [vandf]

62. Methylphenidate Hydrochloride [who-dd]

63. D03721

64. Dexmethylphenidate Hydrochloride [mart.]

65. Dexmethylphenidate Hydrochloride [vandf]

66. Dexmethylphenidate Hydrochloride [who-dd]

67. Methylphenidate Hydrochloride [orange Book]

68. Methylphenidate Hydrochloride Cii [usp-rs]

69. Methylphenidate Hydrochloride [ep Monograph]

70. Methylphenidate Hydrochloride [usp Monograph]

71. Dexmethylphenidate Hydrochloride [orange Book]

72. Methylphenidate D-threo-form Hydrochloride [mi]

73. Q47487562

74. Azstarys Component Dexmethylphenidate Hydrochloride

75. Dexmethylphenidate Hydrochloride Component Of Azstarys

76. Methyl Phenyl(piperidin-2-yl)acetate--hydrogen Chloride (1/1)

77. Methylphenidate Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

78. 2-piperidineacetic Acid, .alpha.-phenyl-, Methyl Ester, Hydrochloride, (r*,r*)-(+/-)-

79. 2-piperidineacetic Acid, .alpha.-phenyl-, Methyl Ester, Hydrochloride,(.alpha.r,2r)-

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 269.77 g/mol
Molecular Formula C14H20ClNO2
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count3
Rotatable Bond Count4
Exact Mass269.1182566 g/mol
Monoisotopic Mass269.1182566 g/mol
Topological Polar Surface Area38.3 Ų
Heavy Atom Count18
Formal Charge0
Complexity249
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameDexmethylphenidate hydrochloride
Drug LabelFocalin (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo-enantiomers. Focalin is a central nervous system (CNS) stimulant, available in 3 tabl...
Active IngredientDexmethylphenidate hydrochloride
Dosage FormTablet; Capsule, extended release
Routeoral; Oral
Strength2.5mg; 5mg; 25mg; 30mg; 10mg; 15mg; 40mg; 20mg
Market StatusTentative Approval; Prescription
CompanyWatson Labs; Mylan Pharms; Teva Pharms; Intellipharmaceutics; Teva Pharms Usa

2 of 6  
Drug NameFocalin
PubMed HealthDexmethylphenidate (By mouth)
Drug ClassesCNS Stimulant
Drug LabelFocalin (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo-enantiomers. Focalin is a central nervous system (CNS) stimulant, available in 3 tabl...
Active IngredientDexmethylphenidate hydrochloride
Dosage FormTablet
RouteOral
Strength2.5mg; 5mg; 10mg
Market StatusPrescription
CompanyNovartis

3 of 6  
Drug NameFocalin xr
PubMed HealthDexmethylphenidate (By mouth)
Drug ClassesCNS Stimulant
Drug LabelFocalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Focalin XR uses the proprietary SODAS (Spheroidal Oral Drug Absorption System) technology. Each bead-filled Focalin XR capsule contains half the dose...
Active IngredientDexmethylphenidate hydrochloride
Dosage FormCapsule, extended release
RouteOral
Strength25mg; 30mg; 15mg; 5mg; 10mg; 40mg; 20mg; 35mg
Market StatusPrescription
CompanyNovartis

4 of 6  
Drug NameDexmethylphenidate hydrochloride
Drug LabelFocalin (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo-enantiomers. Focalin is a central nervous system (CNS) stimulant, available in 3 tabl...
Active IngredientDexmethylphenidate hydrochloride
Dosage FormTablet; Capsule, extended release
Routeoral; Oral
Strength2.5mg; 5mg; 25mg; 30mg; 10mg; 15mg; 40mg; 20mg
Market StatusTentative Approval; Prescription
CompanyWatson Labs; Mylan Pharms; Teva Pharms; Intellipharmaceutics; Teva Pharms Usa

5 of 6  
Drug NameFocalin
PubMed HealthDexmethylphenidate (By mouth)
Drug ClassesCNS Stimulant
Drug LabelFocalin (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo-enantiomers. Focalin is a central nervous system (CNS) stimulant, available in 3 tabl...
Active IngredientDexmethylphenidate hydrochloride
Dosage FormTablet
RouteOral
Strength2.5mg; 5mg; 10mg
Market StatusPrescription
CompanyNovartis

6 of 6  
Drug NameFocalin xr
PubMed HealthDexmethylphenidate (By mouth)
Drug ClassesCNS Stimulant
Drug LabelFocalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Focalin XR uses the proprietary SODAS (Spheroidal Oral Drug Absorption System) technology. Each bead-filled Focalin XR capsule contains half the dose...
Active IngredientDexmethylphenidate hydrochloride
Dosage FormCapsule, extended release
RouteOral
Strength25mg; 30mg; 15mg; 5mg; 10mg; 40mg; 20mg; 35mg
Market StatusPrescription
CompanyNovartis

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Dopamine Uptake Inhibitors

Drugs that block the transport of DOPAMINE into axon terminals or into storage vesicles within terminals. Most of the ADRENERGIC UPTAKE INHIBITORS also inhibit dopamine uptake. (See all compounds classified as Dopamine Uptake Inhibitors.)


Central Nervous System Stimulants

A loosely defined group of drugs that tend to increase behavioral alertness, agitation, or excitation. They work by a variety of mechanisms, but usually not by direct excitation of neurons. The many drugs that have such actions as side effects to their main therapeutic use are not included here. (See all compounds classified as Central Nervous System Stimulants.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Central Nervous System Stimulation [PE]; Central Nervous System Stimulant [EPC]

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30-Sep-2024
30-Sep-2024
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GRANULES

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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG

Approval Date : 2020-09-09

Application Number : 213813

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Granules India

02

GRANULES

India
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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RLD : No

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2020-09-09

Application Number : 213813

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Granules India

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GRANULES

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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 15MG

Approval Date : 2020-09-09

Application Number : 213813

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 20MG

Approval Date : 2020-09-09

Application Number : 213813

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Granules India

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GRANULES

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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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RLD : No

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 25MG

Approval Date : 2020-09-09

Application Number : 213813

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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GRANULES

India
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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RLD : No

TE Code : AB

DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 30MG

Approval Date : 2020-09-09

Application Number : 213813

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Granules India

07

GRANULES

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

RLD : No

TE Code : AB

DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 35MG

Approval Date : 2020-09-09

Application Number : 213813

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Granules India

08

GRANULES

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

RLD : No

TE Code : AB

DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 40MG

Approval Date : 2020-09-09

Application Number : 213813

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Granules India

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 2.5MG

Approval Date : 2017-09-25

Application Number : 209468

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 40MG

Approval Date : 2013-11-19

Application Number : 202731

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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DOSAGE - TABLET;ORAL - 10MG

USFDA APPLICATION NUMBER - 21278

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DOSAGE - TABLET;ORAL - 2.5MG

USFDA APPLICATION NUMBER - 21278

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DOSAGE - TABLET;ORAL - 5MG

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10MG

USFDA APPLICATION NUMBER - 21802

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15MG

USFDA APPLICATION NUMBER - 21802

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20MG

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30MG

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 35M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 35MG

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40MG

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG

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01

Brand Name : Neoral/Sandimmun(e)

Dexmethylphenidate

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CRS
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Brand Name : Neoral/Sandimmun(e)

Switzerland
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Dexmethylphenidate

Main Therapeutic Indication : CNS & Anesthesia

Currency : USD

2020 Revenue in Millions : 393

2019 Revenue in Millions : 419

Growth (%) : -6

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Brand Name : Neoral/Sandimmun(e)

Dexmethylphenidate

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Brand Name : Neoral/Sandimmun(e)

Switzerland
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Dexmethylphenidate

Main Therapeutic Indication : Neurology

Currency : USD

2021 Revenue in Millions : 368

2020 Revenue in Millions : 393

Growth (%) : -6

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03

Brand Name : Ritalin/Focalin

Dexmethylphenidate

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CRS
Not Confirmed

Brand Name : Ritalin/Focalin

Switzerland
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CRS
Not Confirmed

Dexmethylphenidate

Main Therapeutic Indication : Neurological/Mental Disorders

Currency : USD

2016 Revenue in Millions : 282

2015 Revenue in Millions : 365

Growth (%) : -23

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04

Brand Name : Ritalin/Focalin

Dexmethylphenidate

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CRS
Not Confirmed

Brand Name : Ritalin/Focalin

Switzerland
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CRS
Not Confirmed

Dexmethylphenidate

Main Therapeutic Indication : Neurological/Mental Disorders

Currency : USD

2017 Revenue in Millions : 236

2016 Revenue in Millions : 282

Growth (%) : -16

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05

Brand Name : Neoral/Sandimmun(E)

Dexmethylphenidate

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CRS
Not Confirmed

Brand Name : Neoral/Sandimmun(E)

Switzerland
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CRS
Not Confirmed

Dexmethylphenidate

Main Therapeutic Indication : Neurological/Mental Disorders

Currency : USD

2018 Revenue in Millions : 463

2017 Revenue in Millions : 488

Growth (%) : -5%

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06

Brand Name : Neoral/Sandimmun(e)

Dexmethylphenidate

arrow
CRS
Not Confirmed

Brand Name : Neoral/Sandimmun(e)

Switzerland
arrow
CRS
Not Confirmed

Dexmethylphenidate

Main Therapeutic Indication : CNS & Anesthesia

Currency : USD

2019 Revenue in Millions : 419

2018 Revenue in Millions : 463

Growth (%) : -10

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US Patents

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01

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IFT FIRST
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COMMAVE THERAP

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DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE

US Patent Number : 10759778

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 212994

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-12-09

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DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE

US Patent Number : 10954213

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Application Number : 212994

Patent Use Code : U-3094

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Patent Expiration Date : 2037-12-09

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US Patent Number : 10584113

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US Patent Number : 10858341

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US Patent Number : 9079928

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US Patent Number : 10584112

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US Patent Number : 10759778

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Biovail Corporation

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Dexmethylphenidate

Brand Name : ATTENADE

Patent Number : 2241611

Filing Date : 1998-06-22

Strength per Unit : 10 mg

Dosage Form : Tablet

Human Or VET : Human

Route of Administration : Oral

Patent Expiration Date : 2018-06-22

Date Granted : 2004-08-17

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Biovail Corporation

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Dexmethylphenidate

Brand Name : ATTENADE

Patent Number : 2240329

Filing Date : 1998-06-11

Strength per Unit : 2.5 mg

Dosage Form : Tablet

Human Or VET : Human

Route of Administration : Oral

Patent Expiration Date : 2018-06-11

Date Granted : 2004-12-28

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Biovail Corporation

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Dexmethylphenidate

Brand Name : ATTENADE

Patent Number : 2241611

Filing Date : 1998-06-22

Strength per Unit : 2.5 mg

Dosage Form : Tablet

Human Or VET : Human

Route of Administration : Oral

Patent Expiration Date : 2018-06-22

Date Granted : 2004-08-17

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Biovail Corporation

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Dexmethylphenidate

Brand Name : ATTENADE

Patent Number : 2240329

Filing Date : 1998-06-11

Strength per Unit : 5 mg

Dosage Form : Tablet

Human Or VET : Human

Route of Administration : Oral

Patent Expiration Date : 2018-06-11

Date Granted : 2004-12-28

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Biovail Corporation

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Dexmethylphenidate

Brand Name : ATTENADE

Patent Number : 2241611

Filing Date : 1998-06-22

Strength per Unit : 5 mg

Dosage Form : Tablet

Human Or VET : Human

Route of Administration : Oral

Patent Expiration Date : 2018-06-22

Date Granted : 2004-08-17

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Biovail Corporation

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Dexmethylphenidate

Brand Name : ATTENADE

Patent Number : 2240329

Filing Date : 1998-06-11

Strength per Unit : 10 mg

Dosage Form : Tablet

Human Or VET : Human

Route of Administration : Oral

Patent Expiration Date : 2018-06-11

Date Granted : 2004-12-28

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ABOUT THIS PAGE

Looking for 19262-68-1 / Dexmethylphenidate API manufacturers, exporters & distributors?

Dexmethylphenidate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Dexmethylphenidate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Dexmethylphenidate manufacturer or Dexmethylphenidate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dexmethylphenidate manufacturer or Dexmethylphenidate supplier.

PharmaCompass also assists you with knowing the Dexmethylphenidate API Price utilized in the formulation of products. Dexmethylphenidate API Price is not always fixed or binding as the Dexmethylphenidate Price is obtained through a variety of data sources. The Dexmethylphenidate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Dexmethylphenidate

Synonyms

Dexmethylphenidate hcl, Focalin, D-threo-methylphenidate hydrochloride, 19262-68-1, Focalin xr, 23655-65-4

Cas Number

19262-68-1

Unique Ingredient Identifier (UNII)

1678OK0E08

About Dexmethylphenidate

A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.

Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride Manufacturers

A Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride, including repackagers and relabelers. The FDA regulates Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride Suppliers

A Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride supplier is an individual or a company that provides Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride active pharmaceutical ingredient (API) or Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride finished formulations upon request. The Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride suppliers may include Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride USDMF

A Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride DMFs exist exist since differing nations have different regulations, such as Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride USDMF includes data on Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride suppliers with USDMF on PharmaCompass.

Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride suppliers with NDC on PharmaCompass.

Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride GMP

Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride GMP manufacturer or Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride GMP API supplier for your needs.

Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride CoA

A Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride's compliance with Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride specifications and serves as a tool for batch-level quality control.

Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride EP), Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Novartis Pharmaceutical Brand of Dexmethylphenidate Hydrochloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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