Metformin Hydrochloride
These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
Approved
Approval ID
33155746-c2ef-12f4-e063-6294a90a039c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 18, 2025
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 Code68071-3833
Application NumberANDA209882
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 18, 2025
FDA Product Classification
INGREDIENTS (8)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 850 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/18/2025
BOXED WARNING SECTION
LOINC: 34066-1Updated: 8/21/2023
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 8/21/2023
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 8/21/2023
WARNINGS AND PRECAUTIONS SECTION
LOINC: 43685-7Updated: 8/21/2023
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 8/21/2023
DRUG INTERACTIONS SECTION
LOINC: 34073-7Updated: 8/21/2023
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 8/21/2023
DOSAGE FORMS & STRENGTHS SECTION
LOINC: 43678-2Updated: 8/21/2023
USE IN SPECIFIC POPULATIONS SECTION
LOINC: 43684-0Updated: 8/21/2023
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 8/21/2023
DESCRIPTION SECTION
LOINC: 34089-3Updated: 8/21/2023
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 8/21/2023
NONCLINICAL TOXICOLOGY SECTION
LOINC: 43680-8Updated: 8/21/2023
CLINICAL STUDIES SECTION
LOINC: 34092-7Updated: 8/21/2023
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 8/21/2023
INFORMATION FOR PATIENTS SECTION
LOINC: 34076-0Updated: 8/21/2023
SPL PATIENT PACKAGE INSERT SECTION
LOINC: 42230-3Updated: 8/21/2023