Metformin hydrochloride
Approved
Approval ID
5909a843-51d7-4cc2-a2ad-b848463e85b6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 19, 2014
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 ER
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51655-562
Application NumberANDA076869
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin hydrochloride ER
Product Specifications
Route of AdministrationORAL
Effective DateJune 19, 2014
FDA Product Classification
INGREDIENTS (1)
METFORMIN HYDROCHLORIDEActive
Quantity: 750 mg in 1 1
Code: 786Z46389E
Classification: ACTIB