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
NDC Product Code42291-456
Application NumberANDA208165
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 1, 2025
Generic NameOxybutynin Chloride
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