Oxybutynin Chloride
These highlights do not include all the information needed to use oxybutynin chloride extended-release tablets safely and effectively. See full prescribing information for oxybutynin chloride extended-release tablets. OXYBUTYNIN chloride extended-release tablets, USP for oral use. Initial U.S. Approval: 1975
Approved
Approval ID
301a7fca-c556-4b53-899f-bc7e2a74ded8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 13, 2016
Manufacturers
FDA
Marlex Pharmaceuticals Inc
DUNS: 782540215
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxybutynin Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10135-611
Application NumberANDA204010
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxybutynin Chloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2019
FDA Product Classification
INGREDIENTS (11)
OXYBUTYNIN CHLORIDEActive
Quantity: 15 mg in 1 1
Code: L9F3D9RENQ
Classification: ACTIB
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
Oxybutynin Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10135-609
Application NumberANDA204010
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxybutynin Chloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2019
FDA Product Classification
INGREDIENTS (13)
OXYBUTYNIN CHLORIDEActive
Quantity: 5 mg in 1 1
Code: L9F3D9RENQ
Classification: ACTIB
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
Oxybutynin Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10135-610
Application NumberANDA204010
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxybutynin Chloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2019
FDA Product Classification
INGREDIENTS (13)
OXYBUTYNIN CHLORIDEActive
Quantity: 10 mg in 1 1
Code: L9F3D9RENQ
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT