Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
Products1
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 Code
71335-1494Application Number
ANDA209335Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 23, 2023FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
OxybutyninActive
Code: L9F3D9RENQClass: ACTIBQuantity: 5 mg in 1 1