Metformin Hydrochloride
These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
Approved
Approval ID
1935bee4-1f47-44ca-981c-0429ae9b78d4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 18, 2023
Manufacturers
FDA
Calvin Scott & Co., Inc.
DUNS: 073404626
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
METFORMIN HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17224-318
Application NumberANDA205096
Product Classification
M
Marketing Category
C73584
G
Generic Name
METFORMIN HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateApril 18, 2023
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB