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oxybutynin

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, for oral use Initial U.S. Approval: 1975

Approved
Approval ID

c042bf06-79a3-4dc7-ae05-3ef3cfae9d44

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 7, 2023

Manufacturers
FDA

Zydus Pharmaceuticals USA Inc.

DUNS: 156861945

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

oxybutynin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68382-257
Application NumberANDA202332
Product Classification
M
Marketing Category
C73584
G
Generic Name
oxybutynin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification

INGREDIENTS (11)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
OXYBUTYNIN CHLORIDEActive
Quantity: 15 mg in 1 1
Code: L9F3D9RENQ
Classification: ACTIB
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT

oxybutynin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68382-255
Application NumberANDA202332
Product Classification
M
Marketing Category
C73584
G
Generic Name
oxybutynin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification

INGREDIENTS (11)

OXYBUTYNIN CHLORIDEActive
Quantity: 5 mg in 1 1
Code: L9F3D9RENQ
Classification: ACTIB
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT

oxybutynin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68382-256
Application NumberANDA202332
Product Classification
M
Marketing Category
C73584
G
Generic Name
oxybutynin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification

INGREDIENTS (11)

HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
OXYBUTYNIN CHLORIDEActive
Quantity: 10 mg in 1 1
Code: L9F3D9RENQ
Classification: ACTIB
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT

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oxybutynin - FDA Drug Approval Details