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Metformin ER 500 mg

Prescription ANDA TE AB1

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name

Metformin ER 500 mg

Generic name

Metformin ER 500 mg

Dosage form

Tablet

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Quallent Pharmaceuticals Health LLC

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

55% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Metformin Hydrochloride	500 mg/1	860975	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet

Route of administration

Oral

Presentations

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Biguanide [EPC]	EPC	All 47 members
Biguanides [CS]	CS	All 47 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

209313

Application type

ANDA · Abbreviated New Drug Application

Approval date

March 16, 2018

Sponsor

GRANULES

Products on application

Submissions recorded

Products approved under application 209313.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
209313-001	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE		METFORMIN HYDROCHLORIDE	Prescription	AB1
209313-002	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE		METFORMIN HYDROCHLORIDE	Prescription	AB

Therapeutic equivalence

Source: Orange Book

TE code

AB1

Reference Listed Drug

Reference Standard

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 209313.
Type	No.	Action	Status	Date	Review
Supplement	32	Labeling	Approved	August 11, 2026	Standard
Supplement	11	Labeling	Approved	July 27, 2026	Standard
Supplement	1	Labeling	Approved	January 14, 2019	Standard
Original application	1		Approved	March 16, 2018	Standard

Adverse event reports

Source: openFDA FAERS

91,381

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: METFORMIN HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Recalls

Source: FDA Enforcement

Drug recall enforcement reports associated with this product.
Classification	Reported	Firm	Reason	Status
Class II	January 15, 2025	Granules Pharmaceuticals Inc.	Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.	Terminated

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
62207-491-31	62207-491	Granules India Ltd	5000 TABLET in 1 POUCH (62207-491-31)	June 28, 2018
62207-491-35	62207-491	Granules India Ltd	25000 TABLET in 1 CARTON (62207-491-35)	June 28, 2018
62207-491-43	62207-491	Granules India Ltd	100 TABLET in 1 BOTTLE (62207-491-43)	July 25, 2019
62207-491-47	62207-491	Granules India Ltd	500 TABLET in 1 BOTTLE (62207-491-47)	July 25, 2019
62207-491-49	62207-491	Granules India Ltd	1000 TABLET in 1 BOTTLE (62207-491-49)	July 25, 2019
62207-491-54	62207-491	Granules India Ltd	30 TABLET in 1 BOTTLE (62207-491-54)	July 25, 2019
82009-117-10	82009-117	Quallent Pharmaceuticals Health LLC	1000 TABLET in 1 BOTTLE (82009-117-10)	July 25, 2023
62207-491	62207-491	Granules India Ltd	—	June 28, 2018
82009-117	82009-117	Quallent Pharmaceuticals Health LLC	—	July 25, 2023

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS	FDA	Adverse event report counts
Enforcement	FDA	Recall records

Generated September 25, 2026 · 11 sections on this page.