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Chemistry

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Also known as: 4682-36-4, Norflex, Banflex, Orphenadrine dihydrogen citrate, Flexon, Orphenadrine (citrate)
Molecular Formula
C24H31NO8
Molecular Weight
461.5  g/mol
InChI Key
MMMNTDFSPSQXJP-UHFFFAOYSA-N
FDA UNII
X0A40N8I4S

Orphenadrine
A muscarinic antagonist used to treat drug-induced parkinsonism and to relieve pain from muscle spasm.
1 2D Structure

Orphenadrine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N,N-dimethyl-2-[(2-methylphenyl)-phenylmethoxy]ethanamine;2-hydroxypropane-1,2,3-tricarboxylic acid
2.1.2 InChI
InChI=1S/C18H23NO.C6H8O7/c1-15-9-7-8-12-17(15)18(20-14-13-19(2)3)16-10-5-4-6-11-16;7-3(8)1-6(13,5(11)12)2-4(9)10/h4-12,18H,13-14H2,1-3H3;13H,1-2H2,(H,7,8)(H,9,10)(H,11,12)
2.1.3 InChI Key
MMMNTDFSPSQXJP-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=CC=CC=C1C(C2=CC=CC=C2)OCCN(C)C.C(C(=O)O)C(CC(=O)O)(C(=O)O)O
2.2 Other Identifiers
2.2.1 UNII
X0A40N8I4S
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Citrate, Norflex Orphenadrine

2. Citrate, Orphenadrine

3. Disipal

4. Hydrochloride, Orphenadrine

5. Lysantin

6. Mefenamine

7. Mefenamine, Sodium

8. Mephenamine

9. Methyldiphenylhydramine

10. Norflex

11. Norflex Orphenadrine Citrate

12. Orphenadrine

13. Orphenadrine Citrate, Norflex

14. Orphenadrine Hydrochloride

15. Sodium Mefenamine

2.3.2 Depositor-Supplied Synonyms

1. 4682-36-4

2. Norflex

3. Banflex

4. Orphenadrine Dihydrogen Citrate

5. Flexon

6. Orphenadrine (citrate)

7. Flexoject

8. X-otag

9. Orphenadrine Citrate Salt

10. 2-hydroxypropane-1,2,3-tricarboxylic Acid; Dimethyl({2-[(2-methylphenyl)(phenyl)methoxy]ethyl})amine

11. 4596-23-0

12. Nsc-757238

13. Orphenadrine Citrate [usp]

14. N,n-dimethyl-2-[(2-methylphenyl)-phenylmethoxy]ethanamine;2-hydroxypropane-1,2,3-tricarboxylic Acid

15. Orphenadrine Citrate (norflex)

16. Chebi:7790

17. X0a40n8i4s

18. N,n-dimethyl-2-(phenyl(o-tolyl)methoxy)ethanamine 2-hydroxypropane-1,2,3-tricarboxylate

19. Ncgc00094745-01

20. Plenactol

21. Euflex

22. Flexor

23. Tega-flex

24. Orphenadrine Citrate (usp)

25. Dsstox_cid_24678

26. Dsstox_rid_80390

27. Dsstox_gsid_44678

28. Norflex (pharmaceutical)

29. Orphenadrinecitrate

30. N,n-dimethyl-2-(phenyl(o-tolyl)methoxy)ethan-1-amine 2-hydroxypropane-1,2,3-tricarboxylate

31. Cas-4682-36-4

32. Einecs 225-137-5

33. Unii-x0a40n8i4s

34. Norflex (tn)

35. Orphenadine Citrate

36. N,n-dimethyl-2-((o-methyl-alpha-phenylbenzyl)oxy)ethylamine Citrate (1:1)

37. Ethanamine, N,n-dimethyl-2-((2-methylphenyl)phenylmethoxy)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

38. Mls000069549

39. Schembl119470

40. Spectrum1500447

41. Chembl1200395

42. Dtxsid8044678

43. Hms502k15

44. Hy-b0369a

45. Orphenadrine Citrate [mi]

46. Hms1920d10

47. Hms2091l10

48. Hms2231j06

49. Hms3259m21

50. Hms3370m12

51. Hms3651a10

52. Hms3884m22

53. Pharmakon1600-01500447

54. Citric Acid; N,n-dimethyl-2-[o-tolyl(phenyl)methoxy]ethanamine

55. O-methyldiphenhydramine Citrate Salt

56. Orphenadrine Citrate [vandf]

57. Tox21_111323

58. Tox21_113543

59. Tox21_301079

60. Ccg-40242

61. Nsc757238

62. Orphenadrine Citrate [mart.]

63. Orphenadrine Citrate [who-dd]

64. Akos008132385

65. Tox21_111323_1

66. Nc00525

67. Nsc 757238

68. (+-)-n,n-dimethyl-2-((o-methyl-alpha-phenylbenzyl)oxy)ethylamine Citrate (1:1)

69. Ethylamine, N,n-dimethyl-2-((o-methyl-alpha-phenylbenzyl)oxy)-, Citrate (1:1)

70. Ncgc00015771-13

71. Ncgc00094745-02

72. Ncgc00094745-03

73. Ncgc00254980-01

74. As-74807

75. Ethanamine, N,n-dimethyl-2-((2-methylphenyl)phenylmethoxy)-, (+-)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

76. Orphenadrine Citrate [ep Impurity]

77. Orphenadrine Citrate [orange Book]

78. Smr000058817

79. Orphenadrine Citrate [ep Monograph]

80. Orphenadrine Citrate [usp Monograph]

81. Ft-0655842

82. Ft-0673305

83. S2054

84. Sw102176-4

85. En300-53019

86. Norgesic Component Orphenadrine Citrate

87. C75247

88. D00774

89. Invagesic Component Orphenadrine Citrate

90. Orphenadrine Citrate Component Of Norgesic

91. Orphengesic Component Orphenadrine Citrate

92. A826945

93. Orphenadrine Citrate Component Of Invagesic

94. Orphenadrine Citrate Component Of Orphengesic

95. Sr-01000002975-5

96. Invagesic Forte Component Orphenadrine Citrate

97. Orphengesic Forte Component Orphenadrine Citrate

98. Q27107584

99. Orphenadrine Citrate Component Of Invagesic Forte

100. Orphenadrine Citrate Component Of Orphengesic Forte

101. Beta-dimethylaminoethyl 2-methylbenzhydryl Ether Citrate Salt

102. N,n-dimethyl-2-((o-methyl-alpha-phenylbenzyl)oxy)ethylamine Citrate

103. (+-)-n,n-dimethyl-2-((o-methyl-alpha-phenylbenzyl)oxy)ethylamine Citrate

104. (+/-)-n,n-dimethyl-2-((o-methyl-.alpha.-phenylbenzyl)oxy)ethylamine Citrate (1:1)

105. Ethanamine, N,n-dimethyl-2-((2-methylphenyl)phenylmethoxy)-, (+/-)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

106. Ethanamine, N,n-dimethyl-2-[(2-methylphenyl)phenylmethoxy]-,2-hydroxy-1,2,3-propanetricarboxylate (1:1)

107. N,n-dimethyl-2-[(2-methylphenyl)(phenyl)methoxy]ethanamine 2-hydroxypropane-1,2,3-tricarboxylate

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 461.5 g/mol
Molecular Formula C24H31NO8
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count9
Rotatable Bond Count11
Exact Mass461.20496695 g/mol
Monoisotopic Mass461.20496695 g/mol
Topological Polar Surface Area145 Ų
Heavy Atom Count33
Formal Charge0
Complexity488
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameNorflex
PubMed HealthOrphenadrine
Drug ClassesSkeletal Muscle Relaxant, Centrally Acting
Drug LabelOrphenadrine citrate is the citrate salt of orphenadrine (2-dimethylaminoethyl 2- methylbenzhydryl ether citrate). It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly solubl...
Active IngredientOrphenadrine citrate
Dosage FormInjectable
RouteInjection
Strength30mg/ml
Market StatusPrescription
CompanyMedicis

2 of 4  
Drug NameOrphenadrine citrate
PubMed HealthOrphenadrine Citrate/Aspirin/Caffeine (By mouth)
Drug ClassesSkeletal Muscle Relaxant, Centrally Acting/Salicylate, Aspirin Combination
Drug LabelOrphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. The chemical name of orphenadrine citrate i...
Active IngredientOrphenadrine citrate
Dosage FormTablet, extended release; Injectable
RouteInjection; Oral
Strength30mg/ml; 100mg
Market StatusPrescription
CompanyImpax Pharms; Tedor Pharma; Sandoz; Invagen Pharms; Watson Labs; Gavis Pharms; Sagent Pharms; Eurohlth Intl; Akorn

3 of 4  
Drug NameNorflex
PubMed HealthOrphenadrine
Drug ClassesSkeletal Muscle Relaxant, Centrally Acting
Drug LabelOrphenadrine citrate is the citrate salt of orphenadrine (2-dimethylaminoethyl 2- methylbenzhydryl ether citrate). It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly solubl...
Active IngredientOrphenadrine citrate
Dosage FormInjectable
RouteInjection
Strength30mg/ml
Market StatusPrescription
CompanyMedicis

4 of 4  
Drug NameOrphenadrine citrate
PubMed HealthOrphenadrine Citrate/Aspirin/Caffeine (By mouth)
Drug ClassesSkeletal Muscle Relaxant, Centrally Acting/Salicylate, Aspirin Combination
Drug LabelOrphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. The chemical name of orphenadrine citrate i...
Active IngredientOrphenadrine citrate
Dosage FormTablet, extended release; Injectable
RouteInjection; Oral
Strength30mg/ml; 100mg
Market StatusPrescription
CompanyImpax Pharms; Tedor Pharma; Sandoz; Invagen Pharms; Watson Labs; Gavis Pharms; Sagent Pharms; Eurohlth Intl; Akorn

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Cytochrome P-450 CYP2B6 Inhibitors

Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 CYP2B6. (See all compounds classified as Cytochrome P-450 CYP2B6 Inhibitors.)


Antiparkinson Agents

Agents used in the treatment of Parkinson's disease. The most commonly used drugs act on the dopaminergic system in the striatum and basal ganglia or are centrally acting muscarinic antagonists. (See all compounds classified as Antiparkinson Agents.)


Muscarinic Antagonists

Drugs that bind to but do not activate MUSCARINIC RECEPTORS, thereby blocking the actions of endogenous ACETYLCHOLINE or exogenous agonists. Muscarinic antagonists have widespread effects including actions on the iris and ciliary muscle of the eye, the heart and blood vessels, secretions of the respiratory tract, GI system, and salivary glands, GI motility, urinary bladder tone, and the central nervous system. (See all compounds classified as Muscarinic Antagonists.)


Muscle Relaxants, Central

A heterogeneous group of drugs used to produce muscle relaxation, excepting the neuromuscular blocking agents. They have their primary clinical and therapeutic uses in the treatment of muscle spasm and immobility associated with strains, sprains, and injuries of the back and, to a lesser degree, injuries to the neck. They have been used also for the treatment of a variety of clinical conditions that have in common only the presence of skeletal muscle hyperactivity, for example, the muscle spasms that can occur in MULTIPLE SCLEROSIS. (From Smith and Reynard, Textbook of Pharmacology, 1991, p358) (See all compounds classified as Muscle Relaxants, Central.)


Parasympatholytics

Agents that inhibit the actions of the parasympathetic nervous system. The major group of drugs used therapeutically for this purpose is the MUSCARINIC ANTAGONISTS. (See all compounds classified as Parasympatholytics.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Muscle Relaxant [EPC]; Centrally-mediated Muscle Relaxation [PE]
5.3 ATC Code

M - Musculo-skeletal system

M03 - Muscle relaxants

M03B - Muscle relaxants, centrally acting agents

M03BC - Ethers, chemically close to antihistamines

M03BC01 - Orphenadrine (citrate)


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A30,A.I.E","city":"HYDERABAD,TELANGANA","supplier":"RISING PHARMA HOLDINGS INC","supplierCountry":"UNITED STATES","foreign_port":"NEW YORK","customer":"ANTHEA PHARMA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"10.15","actualQuantity":"10.15","unit":"KGS","unitRateFc":"537.3","totalValueFC":"5504.9","currency":"USD","unitRateINR":"46426.2","date":"22-Apr-2025","totalValueINR":"471225.6","totalValueInUsd":"5504.9","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"9642255","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NEW YORK","supplierAddress":"150 S WYCKLES ROAD, DECATUR, IL SDNF SDNF UNITED STATES","customerAddress":"SHANKAR TOWERS PLOT NO. A30,A.I.E"}]
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23-Apr-2025
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ABOUT THIS PAGE

Looking for 4724-58-7 / Orphenadrine API manufacturers, exporters & distributors?

Orphenadrine manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Orphenadrine 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 Orphenadrine manufacturer or Orphenadrine supplier for your needs.

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

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

API | Excipient name

Orphenadrine

Synonyms

4682-36-4, Norflex, Banflex, Orphenadrine dihydrogen citrate, Flexon, Orphenadrine (citrate)

Cas Number

4724-58-7

Unique Ingredient Identifier (UNII)

X0A40N8I4S

About Orphenadrine

A muscarinic antagonist used to treat drug-induced parkinsonism and to relieve pain from muscle spasm.

Orphenadrine Manufacturers

A Orphenadrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Orphenadrine, including repackagers and relabelers. The FDA regulates Orphenadrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Orphenadrine 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 Orphenadrine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Orphenadrine Suppliers

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

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

Orphenadrine USDMF

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

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

click here to find a list of Orphenadrine suppliers with USDMF on PharmaCompass.

Orphenadrine KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Orphenadrine Drug Master File in Korea (Orphenadrine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Orphenadrine. The MFDS reviews the Orphenadrine KDMF as part of the drug registration process and uses the information provided in the Orphenadrine KDMF to evaluate the safety and efficacy of the drug.

After submitting a Orphenadrine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Orphenadrine API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Orphenadrine suppliers with KDMF on PharmaCompass.

Orphenadrine CEP

A Orphenadrine CEP of the European Pharmacopoeia monograph is often referred to as a Orphenadrine Certificate of Suitability (COS). The purpose of a Orphenadrine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Orphenadrine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Orphenadrine to their clients by showing that a Orphenadrine CEP has been issued for it. The manufacturer submits a Orphenadrine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Orphenadrine CEP holder for the record. Additionally, the data presented in the Orphenadrine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Orphenadrine DMF.

A Orphenadrine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Orphenadrine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Orphenadrine suppliers with CEP (COS) on PharmaCompass.

Orphenadrine WC

A Orphenadrine written confirmation (Orphenadrine WC) is an official document issued by a regulatory agency to a Orphenadrine manufacturer, verifying that the manufacturing facility of a Orphenadrine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Orphenadrine APIs or Orphenadrine finished pharmaceutical products to another nation, regulatory agencies frequently require a Orphenadrine WC (written confirmation) as part of the regulatory process.

click here to find a list of Orphenadrine suppliers with Written Confirmation (WC) on PharmaCompass.

Orphenadrine 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 Orphenadrine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Orphenadrine 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 Orphenadrine 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 Orphenadrine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Orphenadrine NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Orphenadrine suppliers with NDC on PharmaCompass.

Orphenadrine GMP

Orphenadrine 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 Orphenadrine 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 Orphenadrine GMP manufacturer or Orphenadrine GMP API supplier for your needs.

Orphenadrine CoA

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

Orphenadrine CoA mostly includes findings from lab analyses of a specific batch. For each Orphenadrine 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.

Orphenadrine may be tested according to a variety of international standards, such as European Pharmacopoeia (Orphenadrine EP), Orphenadrine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Orphenadrine 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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