OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE TABLETS, USP
Approved
Approval ID
f8ed80f2-6c3d-4d7f-b761-c2447973c1f9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 10, 2023
Manufacturers
FDA
Rising Pharmaceuticals, Inc.
DUNS: 041241766
Products 2
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 Code64980-431
Application NumberANDA209025
Product Classification
M
Marketing Category
C73584
G
Generic Name
OXYBUTYNIN CHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 10, 2023
FDA Product Classification
INGREDIENTS (5)
OXYBUTYNIN CHLORIDEActive
Quantity: 5 mg in 1 1
Code: L9F3D9RENQ
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
OXYBUTYNIN CHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64980-531
Application NumberANDA209025
Product Classification
M
Marketing Category
C73584
G
Generic Name
OXYBUTYNIN CHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 10, 2023
FDA Product Classification
INGREDIENTS (5)
OXYBUTYNIN CHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: L9F3D9RENQ
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT