MedPath

Metformin Hydrochloride

Metformin Hydrochloride Tablets, USP

Approved
Approval ID

9411b1e8-6715-4d62-9861-ccc052f65c8e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 30, 2014

Manufacturers
FDA

ReadyMeds

DUNS: 072115132

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 Code64205-220
Application NumberANDA077880
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2014
FDA Product Classification

INGREDIENTS (4)

MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Metformin Hydrochloride - FDA Drug Approval Details