Oxybutynin Chloride
Oxybutynin Chloride Tablets, USP Rx only
Approved
Approval ID
3418ca19-feb0-9821-e063-6394a90ae819
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2025
Manufacturers
FDA
AvKARE
DUNS: 796560394
Products 1
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 Code42291-456
Application NumberANDA208165
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxybutynin Chloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2025
FDA Product Classification
INGREDIENTS (5)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
OXYBUTYNIN CHLORIDEActive
Quantity: 5 mg in 1 1
Code: L9F3D9RENQ
Classification: ACTIB