Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
State of Florida DOH Central Pharmacy
State of Florida DOH Central Pharmacy
829348114
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metformin Hydrochloride
Product Details
NDC Product Code
53808-0848Application Number
ANDA077095Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 15, 2014MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 1000 mg in 1 1
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT