Metformin hydrochloride
Metformin Hydrochloride Tablets USP These highlights do not include all the information needed to use Metformin hydrochloride safely and effectively. See full prescribing information for Metformin hydrochloride Metformin hydrochloride (Metformin hydrochloride) TABLET for ORAL use. Initial U.S. Approval:
Approved
Approval ID
7366efad-8e3c-8bc3-e053-2991aa0a713b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 11, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-4525
Application NumberANDA090564
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 11, 2021
FDA Product Classification
INGREDIENTS (9)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
BLACKBERRYInactive
Code: 8A6OMU3I8L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB