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Chemistry

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Also known as: Oxybutynin hydrochloride, 1508-65-2, Oxybutynin hcl, Tropax, Oxybutynin (chloride), Ditropan xl
Molecular Formula
C22H32ClNO3
Molecular Weight
393.9  g/mol
InChI Key
SWIJYDAEGSIQPZ-UHFFFAOYSA-N
FDA UNII
L9F3D9RENQ

Oxybutynin Hydrochloride
Oxybutynin Chloride is the chloride salt form of oxybutynin, a tertiary amine and anticholinergic agent with antispasmodic activity. Oxybutynin chloride exerts its antimuscarinic effect on bladder smooth muscle by blocking muscarinic receptors in smooth muscle, thereby inhibiting acetylcholine binding. This results in a relaxation of bladder smooth muscle, a reduction of involuntary muscle contractions and delays the initial desire to void.
1 2D Structure

Oxybutynin Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate;hydrochloride
2.1.2 InChI
InChI=1S/C22H31NO3.ClH/c1-3-23(4-2)17-11-12-18-26-21(24)22(25,19-13-7-5-8-14-19)20-15-9-6-10-16-20;/h5,7-8,13-14,20,25H,3-4,6,9-10,15-18H2,1-2H3;1H
2.1.3 InChI Key
SWIJYDAEGSIQPZ-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCN(CC)CC#CCOC(=O)C(C1CCCCC1)(C2=CC=CC=C2)O.Cl
2.2 Other Identifiers
2.2.1 UNII
L9F3D9RENQ
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 4-(diethylamino)-2-butynyl-alpha-cyclohexyl-alpha-hydroxybenzeneacetate

2. 4-(diethylamino)-2-butynyl-alpha-phenylcyclohexaneglycolate

3. Apo-oxybutynin

4. Contimin

5. Cystonorm

6. Cystrin

7. Ditropan

8. Dresplan

9. Dridase

10. Driptane

11. Gelnique

12. Gen-oxybutynin

13. Novo-oxybutynin

14. Nu-oxybutyn

15. Oxyb Abz

16. Oxybugamma

17. Oxybutin Holsten

18. Oxybuton

19. Oxybutynin

20. Oxybutynin Al

21. Oxybutynin Azu

22. Oxybutynin Heumann

23. Oxybutynin Hexal

24. Oxybutynin Hydrochloride

25. Oxybutynin Stada

26. Oxybutynin Von Ct

27. Oxybutynin-puren

28. Oxybutynin-ratiopharm

29. Oxymedin

30. Oxytrol

31. Pms-oxybutynin

32. Pollakisu

33. Renamel

34. Ryol

35. Spasmex Oxybutynin

36. Spasyt

37. Tavor

38. Zatur

2.3.2 Depositor-Supplied Synonyms

1. Oxybutynin Hydrochloride

2. 1508-65-2

3. Oxybutynin Hcl

4. Tropax

5. Oxybutynin (chloride)

6. Ditropan Xl

7. Pollakisu

8. Mj 4309-1

9. L9f3d9renq

10. Nsc-759108

11. Alpha-phenylcyclohexaneglycolic Acid 4-(diethylamino)-2-butynyl Ester Hydrochloride

12. Mls000069688

13. 4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate Hydrochloride

14. Dridase

15. Smr000058490

16. Mj-4309-1

17. 4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate;hydrochloride

18. Oxybutynin Hydrochloride (jan)

19. 4-diethylamino-2-butynyl Phenyl(cyclohexyl)glycolate Hydrochloride

20. 4-(diethylamino)-2-butynyl Alpha-phenylcyclohexaneglycolate Hydrochloride

21. Gelnique

22. Oxibutinina Hydrochloride

23. Oxybutynin Hydrochloride [jan]

24. Chebi:7857

25. 4-diethylaminobut-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylethanoate Hydrochloride

26. Oxybutynin Chloride [usan]

27. Oxybutyninhydrochloride

28. Sr-01000000184

29. Einecs 216-139-7

30. Unii-l9f3d9renq

31. 4-(diethylamino)but-2-ynyl Cyclohexylphenylglycolate Hydrochloride

32. Oxybutynin Chloride [usan:usp]

33. Ditropan (tn)

34. Gelnique (tn)

35. Prestwick_621

36. Mfcd00072150

37. Oxybutynin-d11 Hcl

38. 4-(diethylamino)but-2-yn-1-yl Cyclohexyl(hydroxy)phenylacetate Hydrochloride

39. Opera_id_1330

40. Ncgc00016583-01

41. Oxybutynin (hydrochloride)

42. Oxybutynin Chloride (usp)

43. Cas-1508-65-2

44. Chembl1133

45. Dsstox_cid_25356

46. Dsstox_rid_80822

47. Dsstox_gsid_45356

48. Schembl25751

49. Mls001148211

50. Mls002222232

51. Regid_for_cid_91505

52. Dtxsid3045356

53. Hy-b0267a

54. (s)-4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate Hydrochloride

55. Hms1568j16

56. Pharmakon1600-01505399

57. (r,s) - Oxybutynin Hydrochloride

58. Oxybutynin Chloride [vandf]

59. Bcp12138

60. Oxybutynin Chloride-(phenyl-[d5])

61. Tox21_110507

62. Tox21_500923

63. Nsc759108

64. Oxybutynin Chloride [usp-rs]

65. Oxybutynin Hydrochloride [mi]

66. S3117

67. 4-(diethylamino)-2-butynyl (+-)-alpha-phenylcyclohexaneglycolate Hydrochloride

68. Akos015895349

69. Ccg-213420

70. H33o205

71. Ks-1377

72. Lp00923

73. Nc00580

74. Nsc 759108

75. Cyclohexaneglycolic Acid, Alpha-phenyl-, 4-(diethylamino)-2-butynyl Ester, Hydrochloride

76. Oxybutynin Hydrochloride [mart.]

77. Ncgc00094234-01

78. Ncgc00094234-02

79. Ncgc00261608-01

80. Oxybutynin Chloride [orange Book]

81. Oxybutynin Hydrochloride [who-dd]

82. Benzeneacetic Acid, Alpha-cyclohexyl-alpha-hydroxy-, 4-(diethylamino)-2-butynyl Ester Hydrochloride

83. Benzeneacetic Acid, Alpha-cyclohexyl-alpha-hydroxy-, 4-(diethylamino)-2-butynyl Ester Hydrochloride, (+-)-

84. Bo166187

85. Oxybutynin Chloride [usp Impurity]

86. Oxybutynin Chloride [usp Monograph]

87. Eu-0100923

88. Ft-0603563

89. Ft-0673411

90. Ft-0673412

91. O0451

92. Oxybutynin Chloride, >=98% (tlc), Powder

93. Sw196787-4

94. A51042

95. D00722

96. O 2881

97. Oxybutynin Hydrochloride [ep Monograph]

98. Oxybutynin Hydrochloride [usp Impurity]

99. A809082

100. J-008750

101. Sr-01000000184-2

102. Sr-01000000184-7

103. Q27107600

104. Oxybutynin Chloride, Meets Ep, Usp Testing Specifications

105. Oxybutynin Chloride, United States Pharmacopeia (usp) Reference Standard

106. Oxybutynin Hydrochloride, British Pharmacopoeia (bp) Reference Standard

107. Oxybutynin Hydrochloride, European Pharmacopoeia (ep) Reference Standard

108. 2-cyclohexyl-2-hydroxy-2-phenylacetic Acid 4-(diethylamino)but-2-ynyl Ester Hcl

109. 4-(diethylamino)-2-butynyl (+/-)-,alpha.-phenylcyclohexaneglycolate Hydrochloride

110. 4-(diethylamino)but-2-yn-1-yl 2-cyclohexyl-2-hydroxy-2-phenylacetate Hydrochloride

111. 4-diethylamino-2-butynylphenyl(cyclohexyl)glycolatehydrochloride;oxybutynin Hcl

112. Alpha-phenylcyclohexaneglycolic Acid 4-(diethylamino)-2-butynyl Ester, Hydrochloride

113. Benezeneactetic Acid, .alpha.-cyclohexyl-.alpha.-hydroxy-,4-(diethylamino-2-butunyl Ester Hydrochloride,(+/-)-

114. Benzeneacetic Acid, .alpha.-cyclohexyl-.alpha.-hydroxy-, 4-(diethylamino)-2-butynyl Ester Hydrochloride, (+/-)-

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 393.9 g/mol
Molecular Formula C22H32ClNO3
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count4
Rotatable Bond Count8
Exact Mass393.2070716 g/mol
Monoisotopic Mass393.2070716 g/mol
Topological Polar Surface Area49.8 Ų
Heavy Atom Count27
Formal Charge0
Complexity490
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 8  
Drug NameDitropan xl
Drug LabelDITROPAN XL (oxybutynin chloride) is an antispasmodic, anticholinergic agent. Each DITROPAN XL Extended Release Tablet contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral admini...
Active IngredientOxybutynin chloride
Dosage FormTablet, extended release
RouteOral
Strength5mg; 10mg; 15mg
Market StatusPrescription
CompanyJanssen Pharms

2 of 8  
Drug NameGelnique
PubMed HealthOxybutynin (By mouth)
Drug ClassesUrinary Antispasmodic
Drug LabelOxybutynin is an antispasmodic, antimuscarinic agent. GELNIQUE (oxybutynin chloride) is a clear and colorless hydroalcoholic gel containing 100 mg oxybutynin chloride per gram of gel. GELNIQUE is available in a 1 gram (1.14 mL) unit dose that contain...
Active IngredientOxybutynin chloride
Dosage FormGel
RouteTransdermal
Strength10%(100mg/packet)
Market StatusPrescription
CompanyWatson Labs

3 of 8  
Drug NameOxybutynin chloride
Drug LabelOxybutynin chloride tablets USP are a debossed, very pale blue, round, biconvex, scored tablet containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochlor...
Active IngredientOxybutynin chloride
Dosage FormTablet, extended release; Tablet; Syrup
RouteOral
Strength15mg; 5mg; 10mg; 5mg/5ml
Market StatusPrescription
CompanyVintage Pharms; Impax Pharms; Mylan Pharms; Wockhardt; Silarx; Pharm Assoc; Teva Pharms Usa; Osmotica Pharm; Usl Pharma; Mylan

4 of 8  
Drug NameOxybutynin chloride
PubMed HealthOxybutynin
Drug ClassesUrinary Antispasmodic
Drug LabelOxybutynin chloride tablets USP are a debossed, very pale blue, round, biconvex, scored tablet containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochlor...
Active IngredientOxybutynin chloride
Dosage FormTablet, extended release
Routeoral
Strength15 mg.
Market StatusPrescription
CompanyMylan Pharms

5 of 8  
Drug NameDitropan xl
Drug LabelDITROPAN XL (oxybutynin chloride) is an antispasmodic, anticholinergic agent. Each DITROPAN XL Extended Release Tablet contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral admini...
Active IngredientOxybutynin chloride
Dosage FormTablet, extended release
RouteOral
Strength5mg; 10mg; 15mg
Market StatusPrescription
CompanyJanssen Pharms

6 of 8  
Drug NameGelnique
PubMed HealthOxybutynin (By mouth)
Drug ClassesUrinary Antispasmodic
Drug LabelOxybutynin is an antispasmodic, antimuscarinic agent. GELNIQUE (oxybutynin chloride) is a clear and colorless hydroalcoholic gel containing 100 mg oxybutynin chloride per gram of gel. GELNIQUE is available in a 1 gram (1.14 mL) unit dose that contain...
Active IngredientOxybutynin chloride
Dosage FormGel
RouteTransdermal
Strength10%(100mg/packet)
Market StatusPrescription
CompanyWatson Labs

7 of 8  
Drug NameOxybutynin chloride
Drug LabelOxybutynin chloride tablets USP are a debossed, very pale blue, round, biconvex, scored tablet containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochlor...
Active IngredientOxybutynin chloride
Dosage FormTablet, extended release; Tablet; Syrup
RouteOral
Strength15mg; 5mg; 10mg; 5mg/5ml
Market StatusPrescription
CompanyVintage Pharms; Impax Pharms; Mylan Pharms; Wockhardt; Silarx; Pharm Assoc; Teva Pharms Usa; Osmotica Pharm; Usl Pharma; Mylan

8 of 8  
Drug NameOxybutynin chloride
PubMed HealthOxybutynin
Drug ClassesUrinary Antispasmodic
Drug LabelOxybutynin chloride tablets USP are a debossed, very pale blue, round, biconvex, scored tablet containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochlor...
Active IngredientOxybutynin chloride
Dosage FormTablet, extended release
Routeoral
Strength15 mg.
Market StatusPrescription
CompanyMylan Pharms

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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.)


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.)


Urological Agents

Drugs used in the treatment of urological conditions and diseases such as URINARY INCONTINENCE and URINARY TRACT INFECTIONS. (See all compounds classified as Urological Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Cholinergic Muscarinic Antagonists [MoA]; Cholinergic Muscarinic Antagonist [EPC]

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Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731868200,"product":"OXYBUTYNIN HYDROCHLORIDE EP","address":"107A,VINAY BHAVYA COMPLEX","city":"MUMBAI ,MAHARASHTRA","supplier":"HARMAN FINOCHEM","supplierCountry":"INDIA","foreign_port":"TEL AVIV YAFO","customer":"TO ORDER","customerCountry":"ISRAEL","quantity":"16.00","actualQuantity":"16","unit":"KGS","unitRateFc":"732.5","totalValueFC":"10889.3","currency":"USD","unitRateINR":57433.25,"date":"18-Nov-2024","totalValueINR":"918932","totalValueInUsd":"10889.3","indian_port":"Bombay Air","hs_no":"29181990","bill_no":"5690885","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"107A,VINAY BHAVYA COMPLEX, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731868200,"product":"OXYBUTYNIN CHLORIDE EP\/IH","address":"107A,VINAY BHAVYA COMPLEX","city":"MUMBAI ,MAHARASHTRA","supplier":"HARMAN FINOCHEM","supplierCountry":"INDIA","foreign_port":"TUNIS","customer":"TO ORDER","customerCountry":"TUNISIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"710","totalValueFC":"6824.4","currency":"USD","unitRateINR":57590,"date":"18-Nov-2024","totalValueINR":"575900","totalValueInUsd":"6824.4","indian_port":"Bombay Air","hs_no":"29181990","bill_no":"5691730","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"TUNISIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"107A,VINAY BHAVYA COMPLEX, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732559400,"product":"PHARMACEUTICAL RAW MATERIAL-BULK DRUG (MFG TAX INV NO:GST\/INV\/298 DT:31.10.2024) OXYBUTYNIN HYDROCHLORIDE EP","address":"A-201\/202, NAVBHARAT EST.,","city":"MUMBAI ,MAHARASHTRA","supplier":"GEMINI EXPORTS","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"TO THE ORDER OF","customerCountry":"BRAZIL","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"435","totalValueFC":"10034.2","currency":"USD","unitRateINR":33870.811600000001,"date":"26-Nov-2024","totalValueINR":"846770.29","totalValueInUsd":"10034.2","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"5907348","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"A-201\/202, NAVBHARAT EST.,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1649874600,"product":"OXYBUTYNIN HYDROCHLORIDE-OXYBUTYNIN CHLORIDE","address":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,","city":"HYDERABAD,TELANGANA","supplier":"SEQENS","supplierCountry":"FRANCE","foreign_port":"NA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"30.30","actualQuantity":"30.3","unit":"KGS","unitRateFc":"1295","totalValueFC":"43893.7","currency":"EUR","unitRateINR":"109298","date":"14-Apr-2022","totalValueINR":"3311729.4","totalValueInUsd":"43893.7","indian_port":"BOMBAY AIR","hs_no":"29221990","bill_no":"8277446","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1663266600,"product":"OXYBUTYNIN HYDROCHLORIDE -OXYBUTYNIN CHLORIDE","address":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,","city":"HYDERABAD,TELANGANA","supplier":"SEQENS","supplierCountry":"FRANCE","foreign_port":"NA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"1395","totalValueFC":"42194.1","currency":"EUR","unitRateINR":"112716","date":"16-Sep-2022","totalValueINR":"3381480","totalValueInUsd":"42194.1","indian_port":"BOMBAY AIR","hs_no":"29221990","bill_no":"2475107","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1684175400,"product":"OXYBUTYNIN CHLORIDE USP 3 6 1043741 346762","address":"206, DEVAVRATA, SECTOR 17, VASHI,","city":"MUMBAI","supplier":"STRIDES PHARMA SCIENCE","supplierCountry":"UNITED STATES","foreign_port":"LOS ANGELES","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"5.10","actualQuantity":"5.1","unit":"KGS","unitRateFc":"847.4","totalValueFC":"5254.5","currency":"USD","unitRateINR":"84776.8","date":"16-May-2023","totalValueINR":"432361.83","totalValueInUsd":"5254.5","indian_port":"BANGALORE AIR","hs_no":"29221990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"United States","selfForZScoreResived":"Pharma Grade","supplierPort":"LOS ANGELES","supplierAddress":"","customerAddress":"206, DEVAVRATA, SECTOR 17, VASHI,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690223400,"product":"OXYBUTYNIN HYDROCHLORIDE-OXYBUTYNIN CHLORIDE","address":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,","city":"HYDERABAD,TELANGANA","supplier":"SEQENS","supplierCountry":"FRANCE","foreign_port":"NA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"1395","totalValueFC":"39780.4","currency":"EUR","unitRateINR":"130781","date":"25-Jul-2023","totalValueINR":"3269531.664","totalValueInUsd":"39780.4","indian_port":"BOMBAY AIR","hs_no":"29221990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715365800,"product":"1032182: OXYBUTYNIN CHLORIDE","address":"NEELAM CENTRE, B WING, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"SEQENS","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"600","totalValueFC":"24286.7","currency":"USD","unitRateINR":"50610","date":"11-May-2024","totalValueINR":"2024400","totalValueInUsd":"24286.7","indian_port":"Bombay Air","hs_no":"29221990","bill_no":"3433144","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"SITE DE SELOC FRANCE-19, ROUTE DEMEULAN 78520, LIMAYSDNF France","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716402600,"product":"OXYBUTYNIN HYDROCHLORIDE -OXYBUTYNIN CHLORIDE","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"SEQENS","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"VIATRIS","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"1395","totalValueFC":"77403.1","currency":"EUR","unitRateINR":"129037.5","date":"23-May-2024","totalValueINR":"6451875","totalValueInUsd":"77403.1","indian_port":"Bombay Air","hs_no":"29221990","bill_no":"3626351","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"Centre administratif Campus EiffelBatiment Lavoisier - 11, Rue Ella Maillart 91300 Massy France","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722450600,"product":"1032182: OXYBUTYNIN CHLORIDE","address":"NEELAM CENTRE, B WING, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"SEQENS","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"110.00","actualQuantity":"110","unit":"KGS","unitRateFc":"600","totalValueFC":"66528.3","currency":"USD","unitRateINR":"50730","date":"01-Aug-2024","totalValueINR":"5580300","totalValueInUsd":"66528.3","indian_port":"Bombay Air","hs_no":"29221990","bill_no":"4813670","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"19 ROUTE DE MEULAN 78520 LIMAY FRANCESDNF France","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,"}]
08-Feb-2021
26-Nov-2024
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Quantity (KGS) & Unit rate (USD/KGS) over time

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FDF Dossiers

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01

Sanofi

France
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Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Sweden

oxibutyninhydroklorid

Brand Name : Ditropan

Dosage Form : TABLET

Dosage Strength : 5 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Sanofi Company Banner

02

AbbVie Inc

U.S.A
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Duphat
Not Confirmed

OXYBUTYNIN CHLORIDE

Brand Name : GELNIQUE

Dosage Form : GEL;TRANSDERMAL

Dosage Strength : 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2009-01-27

Application Number : 22204

Regulatory Info : DISCN

Registration Country : USA

Abbvie Company Banner

03

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Duphat
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

Regulatory Info : RX

Registration Country : USA

OXYBUTYNIN CHLORIDE

Brand Name : OXYBUTYNIN CHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 1997-10-31

Application Number : 75079

Regulatory Info : RX

Registration Country : USA

Strides Pharma Science

04

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Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

Regulatory Info : RX

Registration Country : USA

OXYBUTYNIN CHLORIDE

Brand Name : OXYBUTYNIN CHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2020-12-17

Application Number : 208165

Regulatory Info : RX

Registration Country : USA

Strides Pharma Science

05

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Duphat
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Oxybutynin Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

06

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Duphat
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Oxybutynin Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 2.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

07

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Not Confirmed
  • fda
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Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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Digital Content Digital Content

Regulatory Info :

Registration Country : India

Oxybutynin Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

08

Duphat
Not Confirmed
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Not Confirmed

OXYBUTYNIN CHLORIDE

Brand Name : OXYBUTYNIN CHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2016-05-27

Application Number : 206121

Regulatory Info : RX

Registration Country : USA

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09

USL PHARMA

United Kingdom
Duphat
Not Confirmed
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USL PHARMA

United Kingdom
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Not Confirmed

OXYBUTYNIN CHLORIDE

Brand Name : OXYBUTYNIN CHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 1988-03-10

Application Number : 70746

Regulatory Info : DISCN

Registration Country : USA

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10

Duphat
Not Confirmed
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OXYBUTYNIN CHLORIDE

Brand Name : OXYBUTYNIN CHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 15MG

Packaging :

Approval Date : 2017-06-26

Application Number : 202332

Regulatory Info : RX

Registration Country : USA

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20897

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 15MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20897

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG ...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20897

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DOSAGE - GEL;TRANSDERMAL - 10% (100MG/PACKET)...DOSAGE - GEL;TRANSDERMAL - 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22204

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ABOUT THIS PAGE

Oxybutynin Hydrochloride Manufacturers

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

Oxybutynin Hydrochloride Suppliers

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

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

Oxybutynin Hydrochloride USDMF

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

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

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

Oxybutynin Hydrochloride JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Oxybutynin Hydrochloride Drug Master File in Japan (Oxybutynin Hydrochloride JDMF) empowers Oxybutynin Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Oxybutynin Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Oxybutynin Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Oxybutynin Hydrochloride suppliers with JDMF on PharmaCompass.

Oxybutynin Hydrochloride KDMF

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

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

After submitting a Oxybutynin Hydrochloride 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 Oxybutynin Hydrochloride API can apply through the Korea Drug Master File (KDMF).

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

Oxybutynin Hydrochloride CEP

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

A Oxybutynin Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oxybutynin Hydrochloride 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 Oxybutynin Hydrochloride suppliers with CEP (COS) on PharmaCompass.

Oxybutynin Hydrochloride WC

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

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

Oxybutynin 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 Oxybutynin Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Oxybutynin Hydrochloride GMP

Oxybutynin 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 Oxybutynin 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 Oxybutynin Hydrochloride GMP manufacturer or Oxybutynin Hydrochloride GMP API supplier for your needs.

Oxybutynin Hydrochloride CoA

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

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

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