Metformin Hydrochloride
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, 500 mg and 750 mg72677212Rx only
Approved
Approval ID
a098f1d0-577e-474e-baab-d200c896a294
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 11, 2010
Manufacturers
FDA
MedVantx, Inc.
DUNS: 806427725
Products 1
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 Code66116-433
Application NumberANDA076269
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2007
FDA Product Classification
INGREDIENTS (5)
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
ETHYLCELLULOSE (7 MPA.S)Inactive
Code: H3UP11403C
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT