Oxybutynin Chloride
Oxybutynin Chloride Tablets, USP
Approved
Approval ID
d2aa1b90-bea7-4a93-b2e7-22710548ff55
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
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 Code53808-0747
Application NumberANDA071655
Product Classification
M
Marketing Category
C73584
G
Generic Name
OXYBUTYNIN CHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJune 7, 2010
FDA Product Classification
INGREDIENTS (6)
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
OXYBUTYNIN CHLORIDEActive
Quantity: 5 mg in 1 1
Code: L9F3D9RENQ
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT