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
56d13a1c-b289-4528-b23c-60f5427b4552
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 3, 2020
Manufacturers
FDA
INDICUS PHARMA LLC
DUNS: 793870606
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24724-015
Application NumberANDA079148
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2018
FDA Product Classification
INGREDIENTS (10)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 850 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Metformin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24724-014
Application NumberANDA079148
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2018
FDA Product Classification
INGREDIENTS (10)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Metformin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24724-016
Application NumberANDA079148
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2018
FDA Product Classification
INGREDIENTS (10)
METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Drug Labeling Information
BOXED WARNING SECTION
LOINC: 34066-1Updated: 6/4/2020