Metformin HCl
Metformin Hydrochloride Tablets USP
Approved
Approval ID
2a511607-04db-42d4-aa3c-8fa10e5ca050
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 10, 2023
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metformin HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53002-4422
Application NumberANDA090564
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin HCl
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 7, 2017
FDA Product Classification
INGREDIENTS (9)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 850 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT