Metformin Hydrochloride
Approved
Approval ID
3cfc5665-ec57-475b-a942-8bc9197b88f0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 22, 2012
Manufacturers
FDA
Life Line Home Care Services, Inc.
DUNS: 844985374
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 Code75921-397
Application NumberANDA075967
Product Classification
M
Marketing Category
C73584
G
Generic Name
metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2012
FDA Product Classification
INGREDIENTS (8)
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT