Metformin Hydrochloride
These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
Approved
Approval ID
dd0ee2bf-f658-42dc-976d-49af0b1f32b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 9, 2019
Manufacturers
FDA
TAGI Pharma, Inc.
DUNS: 963322560
Products 2
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 Code51224-007
Application NumberANDA078321
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2018
FDA Product Classification
INGREDIENTS (7)
Copovidone K25-31Inactive
Code: D9C330MD8B
Classification: IACT
carboxymethylcellulose sodium, unspecified formInactive
Code: K679OBS311
Classification: IACT
Metformin HydrochlorideActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
carboxymethylcellulose sodium, unspecifiedInactive
Code: K679OBS311
Classification: IACT
Metformin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51224-107
Application NumberANDA078321
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2018
FDA Product Classification
INGREDIENTS (7)
Copovidone K25-31Inactive
Code: D9C330MD8B
Classification: IACT
Metformin HydrochlorideActive
Quantity: 750 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
carboxymethylcellulose sodium, unspecified formInactive
Code: K679OBS311
Classification: IACT
carboxymethylcellulose sodium, unspecifiedInactive
Code: K679OBS311
Classification: IACT