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
2387a618-24d8-4813-aa83-9114edb35374
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 9, 2023
Manufacturers
FDA
Granules Pharmaceuticals Inc.
DUNS: 079825711
Products 3
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 Code70010-065
Application NumberANDA090564
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 9, 2023
Generic NameMetformin Hydrochloride
INGREDIENTS (9)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
BLACKBERRYInactive
Code: 8A6OMU3I8L
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Metformin Hydrochloride
PRODUCT DETAILS
NDC Product Code70010-063
Application NumberANDA090564
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 9, 2023
Generic NameMetformin Hydrochloride
INGREDIENTS (9)
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BLACKBERRYInactive
Code: 8A6OMU3I8L
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Metformin Hydrochloride
PRODUCT DETAILS
NDC Product Code70010-064
Application NumberANDA090564
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 9, 2023
Generic NameMetformin Hydrochloride
INGREDIENTS (9)
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
BLACKBERRYInactive
Code: 8A6OMU3I8L
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 850 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT