Metformin HCl ER
Metformin HCL ER 500mg
Approved
Approval ID
184f584a-e684-4866-a6d6-57f003726796
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 22, 2015
Manufacturers
FDA
Northwind Pharmaceuticals
DUNS: 036986393
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metformin Hydrochloride Extended Release
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51655-551
Application NumberANDA077336
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin Hydrochloride Extended Release
Product Specifications
Route of AdministrationORAL
Effective DateMay 22, 2015
FDA Product Classification
INGREDIENTS (8)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT