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
dc65065b-cba0-46d7-8fb5-3368f3210b4d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2023
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
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 Code69238-2125
Application NumberANDA078596
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2023
FDA Product Classification
INGREDIENTS (5)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
Metformin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-2126
Application NumberANDA078596
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2023
FDA Product Classification
INGREDIENTS (5)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 750 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT