Oxybutynin Chloride
OXYBUTYNIN CHLORIDE Tablets USP
Approved
Approval ID
19fba9db-69ff-4136-ad6b-04a33b6b6789
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 18, 2013
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-2157
Application NumberANDA071655
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxybutynin Chloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 18, 2013
FDA Product Classification
INGREDIENTS (7)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
OXYBUTYNIN CHLORIDEActive
Quantity: 5 mg in 1 1
Code: L9F3D9RENQ
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT