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METFORMIN HYDROCHLORIDE

Metformin Hydrochloride Tablets, USP

Approved
Approval ID

cce3253c-0d18-4c77-8b5c-79bafd5f9ed8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 4, 2012

Manufacturers
FDA

STAT Rx USA LLC

DUNS: 786036330

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 Code16590-313
Application NumberANDA077064
Product Classification
M
Marketing Category
C73584
G
Generic Name
METFORMIN HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2012
FDA Product Classification

INGREDIENTS (8)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB

METFORMIN HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16590-397
Application NumberANDA077064
Product Classification
M
Marketing Category
C73584
G
Generic Name
METFORMIN HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2012
FDA Product Classification

INGREDIENTS (8)

METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

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METFORMIN HYDROCHLORIDE - FDA Drug Approval Details