Please Wait

Applying Filters...

Technical details about Methylphenidate Hydrochloride, learn more about the structure, uses, toxicity, action, side effects and more

Methylphenidate Hydrochloride

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

36 Suppliers, 20 USDMF, 16 CEP/COS, 1 JDMF, 6 EU WC, 8 KDMF, 21 NDC API, 18 Listed Suppliers

DEVELOPMENTS

11 Drug(s) in Development

11 Drug(s) in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports

DOSSIERs // Finished Dosage Forms

527 Dossiers, 262 FDA Orange Book, 163 Europe, 49 Canada, 26 South Africa, 27 Listed Dossiers

DRUG PRODUCT COMPOSITION

TABLET;ORAL - 10MG, TABLET;ORAL - 20MG, TABLET;ORAL - 5MG, TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION, EXTENDED RELEASE;ORAL - 5MG/ML, TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 20MG, TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 30MG, TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 40MG, TABLET, EXTENDED RELEASE;ORAL - 18MG, TABLET, EXTENDED RELEASE;ORAL - 27MG, TABLET, EXTENDED RELEASE;ORAL - 36MG, TABLET, EXTENDED RELEASE;ORAL - 54MG, CAPSULE, EXTENDED RELEASE;ORAL - 10MG, CAPSULE, EXTENDED RELEASE;ORAL - 20MG, CAPSULE, EXTENDED RELEASE;ORAL - 30MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, CAPSULE, EXTENDED RELEASE;ORAL - 50MG, CAPSULE, EXTENDED RELEASE;ORAL - 60MG, SOLUTION;ORAL - 10MG/5ML, SOLUTION;ORAL - 5MG/5ML, TABLET, CHEWABLE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

Suppliers, 39 Kerry, 38 BASF, 36 Roquette, 20 Microlex e.U, 20 Corel Pharma Chem, 19 SPI Pharma, 15 Ideal Cures Pvt Ltd, 13 Gangwal Healthcare, 12 Actylis, 11 Sigachi Industries, 11 Gangwal Chemicals, 9 Nanjing Well Pharmaceutical, 9 Seppic, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 8 Rochem International Inc, 6 The Dow Chemical Company, 6 DFE Pharma, 6 Lonza Capsugel, 5 Kima Chemical, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 4 Prachin Chemical, 4 Pharmatrans-Sanaq, 4 Ingredion Pharma Solutions, 4 ACG Worldwide, 4 DKSH, 3 Vertellus, 3 Evonik, 3 Vasa Pharmachem, 2 Seqens, 2 Finar, 2 Shijiazhuang Huaxu Pharmaceutical, 2 Hayashibara, 2 Pharm-RX Chemical, 2 Pfanstiehl, 2 Qualicaps, 2 Nomisma Healthcare, 2 Alcedo Pharmachem, 2 Zhejiang Huakang Pharmaceutical, 1 Ulanqab Kema New Material, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Aeon Procare, 1 Bioplus Life Sciences, 1 Jai Radhe Sales, 1 NEWEDGE Overseas, 1 Nanjing Bold Chemical, 1 Chynops Pharma, 1 Minakem, 1 Boai NKY Pharmaceuticals Ltd

EXCIPIENTS BY APPLICATIONS

97 Fillers, Diluents & Binders, 82 Coating Systems & Additives, 54 Controlled & Modified Release, 42 Direct Compression, 41 Thickeners and Stabilizers, 36 Taste Masking, 30 Solubilizers, 29 Film Formers & Plasticizers, 29 Granulation, 28 Disintegrants & Superdisintegrants, 26 Lubricants & Glidants, 23 Parenteral, 22 Chewable & Orodispersible Aids, 21 Topical, 15 Co-Processed Excipients, 9 Empty Capsules, 8 API Stability Enhancers, 6 Emulsifying Agents, 4 Vegetarian Capsules, 4 Rheology Modifiers, 2 Coloring Agents, 1 Surfactant & Foaming Agents, 1 Soft Gelatin

GLOBAL SALES INFORMATION

101 US Medicaid Prescriptions, 81 Finished Drug Prices

MARKET PLACE

10 APIs, 2 DOSSIERS // FDF, 1 CONTRACT SERVICES

PATENTS

186 US Patents, 6 US Exclusivities, 27 Health Canada Patents

ANALYTICAL SOLUTION(s)

3 EDQM Standards, 2 USP Standards, 3 Other Ref. Standards

DIGITAL CONTENT

4 Data Compilation & Company Tracker #PharmaFlow, 69 News

Also known as: 298-59-9, Centedrin, Centedrine, Methylphenidate hcl, Concerta, Ritalin

Molecular Formula

C₁₄H₂₀ClNO₂

Molecular Weight

269.77 g/mol

InChI Key

JUMYIBMBTDDLNG-UHFFFAOYSA-N

A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE.

1 2D Structure

2D Structure

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

methyl 2-phenyl-2-piperidin-2-ylacetate;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

2.1.3 InChI Key

JUMYIBMBTDDLNG-UHFFFAOYSA-N

2.1.4 Canonical SMILES

COC(=O)C(C1CCCCN1)C2=CC=CC=C2.Cl

2.2 Synonyms

2.2.1 MeSH Synonyms

1. Centedrin

2. Concerta

3. Daytrana

4. Equasym

5. Hydrochloride, Methylphenidate

6. Metadate

7. Methylin

8. Methylphenidate

9. Phenidylate

10. Ritalin

11. Ritalin Sr

12. Ritalin-sr

13. Ritaline

14. Tsentedrin

2.2.2 Depositor-Supplied Synonyms

1. 298-59-9

2. Centedrin

3. Centedrine

4. Methylphenidate Hcl

5. Concerta

6. Ritalin

7. Methylphenidate.hcl

8. Metadate

9. Methylin

10. Metilfenidat Hydrochloride

11. Ritalin Sr

12. H-tic-otbu.hcl

13. Threo-methylphenidate Hydrochloride

14. Daytrana

15. Methylin Er

16. Methylphenidylacetate Hydrochloride

17. Ritalin La

18. Methylphenidate (hydrochloride)

19. Ritalin Hydrochloride

20. Ritalin-sr

21. Methyl 2-phenyl-2-piperidin-2-ylacetate;hydrochloride

22. Nsc-169868

23. Ncgc00091942-01

24. Rilaline

25. Dsstox_cid_886

26. Dsstox_rid_75843

27. Dsstox_gsid_20886

28. Methyl Phenyl(piperidin-2-yl)acetate Hydrochloride

29. Quillichew

30. Quillivant

31. Aptensio

32. Foquest

33. Meridil Hydrochloride

34. Oros Mph

35. Aptensio Xr

36. Rilatine

37. Quillivant Xr

38. Quillichew Er

39. Chebi:31836

40. Cas-298-59-9

41. Nsc 169868

42. Ccris 6258

43. Methyl 2-phenyl-2-(piperidin-2-yl)acetate Hydrochloride

44. Einecs 206-065-3

45. Spd544

46. Spd-544

47. Methylphenidate Hydrochloride Er

48. Concerta (tn)

49. Metadate (tn)

50. Methyl Phenidate Hcl

51. Ritalin (tn)

52. Methyl Alpha-phenyl-2-piperidineacetate Hydrochloride

53. Quillivant Xr (tn)

54. Methylphenidate Hydrochloride [usp:jan]

55. Methylphenidate(ritalin)

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

57. Chembl1722

58. Schembl41067

59. Mls003922100

60. Dtxsid8020886

61. Methylphenidate Hydrochloride Cii

62. Hy-b1091a

63. Pharmakon1600-01505907

64. Bcp34044

65. Tox21_111186

66. Tox21_200309

67. 2-piperidineacetic Acid, Alpha-phenyl-, Methyl Ester, Hydrochloride

68. Mfcd00058191

69. Nsc169868

70. Nsc759278

71. Akos016010356

72. Ccg-213572

73. Cs-4658

74. Nsc-759278

75. Sb13180

76. Wln: T6mtj Byr & Vo1 & Gh

77. 2-piperidineacetic Acid, Alpha-phenyl-, Methyl Ester, Hydrochloride, (r*,r*)-(+-)-

78. Methylphenidate Hydrochloride (jan/usp)

79. Ncgc00257863-01

80. Smr000058998

81. Ft-0672045

82. Ft-0672046

83. Ft-0672048

84. Ft-0672050

85. D01296

86. 298m599

87. 2-piperidineacetic Acid, Methyl Ester, Hydrochloride

88. Methylphenidate Hydrochloride(ritalin Hydrochloride)

89. Methylphenidate Hcl;threo-methylphenidate Hydrochloride

90. Q26840773

91. Methyl 2-phenyl-2-(piperidin-2-yl)acetate Hcl

92. Methylphenidate Hydrochloride, European Pharmacopoeia (ep) Reference Standard

93. Methylphenidate Hydrochloride Solution, (racemic Mixture), Ampule Of 1 Ml, 1.0 Mg/ml In Methanol (as Free Base), Certified Reference Material

2.3 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₄H₂₀ClNO₂
Molecular Weight	269.77 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	4
Exact Mass	269.1182566 g/mol
Monoisotopic Mass	269.1182566 g/mol
Topological Polar Surface Area	38.3 Å²
Heavy Atom Count	18
Formal Charge	0
Complexity	249
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	2
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 16
Drug Name	Concerta
PubMed Health	Methylphenidate
Drug Classes	CNS Stimulant, Central Nervous System Agent
Drug Label	CONCERTA is a central nervous system (CNS) stimulant. CONCERTA is available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have...
Active Ingredient	Methylphenidate hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	54mg; 18mg; 27mg; 36mg
Market Status	Prescription
Company	Janssen Pharms

2 of 16
Drug Name	Metadate cd
PubMed Health	Methylphenidate
Drug Classes	CNS Stimulant, Central Nervous System Agent
Drug Label	METADATE CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by t...
Active Ingredient	Methylphenidate hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	30mg; 50mg; 60mg; 10mg; 40mg; 20mg
Market Status	Prescription
Company	Ucb

3 of 16
Drug Name	Metadate er
PubMed Health	Methylphenidate (By mouth)
Drug Classes	CNS Stimulant, Central Nervous System Agent
Drug Label	METADATE ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) are a mild central nervous system (CNS) stimulant. METADATE ER is available as 20 mg extended-release tablets for oral administration.Methylphenidate hydrochloride is m...
Active Ingredient	Methylphenidate hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	20mg
Market Status	Prescription
Company	Ucb

4 of 16
Drug Name	Methylin er
PubMed Health	Methylphenidate
Drug Classes	CNS Stimulant, Central Nervous System Agent
Drug Label	Methylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available for oral administration as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg. Methylphenidate hydrochloride is methyl -phen...
Active Ingredient	Methylphenidate hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	10mg; 20mg
Market Status	Prescription
Company	Mallinckrodt

5 of 16
Drug Name	Methylphenidate hydrochloride
Drug Label	Methylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available for oral administration as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg. Methylphenidate hydrochloride is methyl -phen...
Active Ingredient	Methylphenidate hydrochloride
Dosage Form	Tablet, extended release; Tablet; Capsule, extended release; Solution
Route	oral; Oral
Strength	10mg/5ml; 18mg; 30mg; 27mg; 36mg; 5mg; 54mg; 50mg; 60mg; 10mg; 5mg/5ml; 40mg; 20mg
Market Status	Tentative Approval; Prescription
Company	Corepharma; Vintage Pharms; Actavis Labs Fl; Sun Pharm Inds; Barr Labs; Mallinckrodt; Watson Labs; Actavis S Atlantic; Teva Pharms; Caraco; Ucb; Kudco Ireland; Tris Pharma

6 of 16
Drug Name	Quillivant xr
Drug Label	QUILLIVANT XR is a powder that, after reconstitution with water, forms an extended-release oral suspension formulation of methylphenidate intended for once daily oral administration. QUILLIVANT XR contains approximately 20% immediate-release and 80%...
Active Ingredient	Methylphenidate hydrochloride
Dosage Form	For suspension, extended release
Route	Oral
Strength	5mg/ml
Market Status	Prescription
Company	Nextwave Pharms

7 of 16
Drug Name	Ritalin
Drug Label	Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system (CNS) stimulant, available as tablets of 5, 10, and 20 mg for oral administration; Ritalin-SR is available as sustained-release tablets of 20 mg for oral admin...
Active Ingredient	Methylphenidate hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	5mg; 10mg; 20mg
Market Status	Prescription
Company	Novartis

8 of 16
Drug Name	Ritalin la
Drug Label	Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. Ritalin LA (methylphenidate hydrochloride) extended-release capsules is an extended-release formulation of methylphenidate with a bi-modal release profile. Ritalin LA uses t...
Active Ingredient	Methylphenidate hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	30mg; 10mg; 40mg; 20mg
Market Status	Prescription
Company	Novartis

9 of 16
Drug Name	Concerta
PubMed Health	Methylphenidate
Drug Classes	CNS Stimulant, Central Nervous System Agent
Drug Label	CONCERTA is a central nervous system (CNS) stimulant. CONCERTA is available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have...
Active Ingredient	Methylphenidate hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	54mg; 18mg; 27mg; 36mg
Market Status	Prescription
Company	Janssen Pharms

10 of 16
Drug Name	Metadate cd
PubMed Health	Methylphenidate
Drug Classes	CNS Stimulant, Central Nervous System Agent
Drug Label	METADATE CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by t...
Active Ingredient	Methylphenidate hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	30mg; 50mg; 60mg; 10mg; 40mg; 20mg
Market Status	Prescription
Company	Ucb

11 of 16
Drug Name	Metadate er
PubMed Health	Methylphenidate (By mouth)
Drug Classes	CNS Stimulant, Central Nervous System Agent
Drug Label	METADATE ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) are a mild central nervous system (CNS) stimulant. METADATE ER is available as 20 mg extended-release tablets for oral administration.Methylphenidate hydrochloride is m...
Active Ingredient	Methylphenidate hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	20mg
Market Status	Prescription
Company	Ucb

12 of 16
Drug Name	Methylin er
PubMed Health	Methylphenidate
Drug Classes	CNS Stimulant, Central Nervous System Agent
Drug Label	Methylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available for oral administration as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg. Methylphenidate hydrochloride is methyl -phen...
Active Ingredient	Methylphenidate hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	10mg; 20mg
Market Status	Prescription
Company	Mallinckrodt

13 of 16
Drug Name	Methylphenidate hydrochloride
Drug Label	Methylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available for oral administration as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg. Methylphenidate hydrochloride is methyl -phen...
Active Ingredient	Methylphenidate hydrochloride
Dosage Form	Tablet, extended release; Tablet; Capsule, extended release; Solution
Route	oral; Oral
Strength	10mg/5ml; 18mg; 30mg; 27mg; 36mg; 5mg; 54mg; 50mg; 60mg; 10mg; 5mg/5ml; 40mg; 20mg
Market Status	Tentative Approval; Prescription
Company	Corepharma; Vintage Pharms; Actavis Labs Fl; Sun Pharm Inds; Barr Labs; Mallinckrodt; Watson Labs; Actavis S Atlantic; Teva Pharms; Caraco; Ucb; Kudco Ireland; Tris Pharma

14 of 16
Drug Name	Quillivant xr
Drug Label	QUILLIVANT XR is a powder that, after reconstitution with water, forms an extended-release oral suspension formulation of methylphenidate intended for once daily oral administration. QUILLIVANT XR contains approximately 20% immediate-release and 80%...
Active Ingredient	Methylphenidate hydrochloride
Dosage Form	For suspension, extended release
Route	Oral
Strength	5mg/ml
Market Status	Prescription
Company	Nextwave Pharms

15 of 16
Drug Name	Ritalin
Drug Label	Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system (CNS) stimulant, available as tablets of 5, 10, and 20 mg for oral administration; Ritalin-SR is available as sustained-release tablets of 20 mg for oral admin...
Active Ingredient	Methylphenidate hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	5mg; 10mg; 20mg
Market Status	Prescription
Company	Novartis

16 of 16
Drug Name	Ritalin la
Drug Label	Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. Ritalin LA (methylphenidate hydrochloride) extended-release capsules is an extended-release formulation of methylphenidate with a bi-modal release profile. Ritalin LA uses t...
Active Ingredient	Methylphenidate hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	30mg; 10mg; 40mg; 20mg
Market Status	Prescription
Company	Novartis

4.2 Drug Indication

Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

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.)

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.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Central Nervous System Stimulation [PE]; Central Nervous System Stimulant [EPC]

POST ENQUIRY