On this page

Glumetza

metformin hydrochloride · Tablet, Film Coated, Extended Release

Prescription NDA TE AB3 RLD

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

Glumetza

Generic name

metformin hydrochloride

Dosage form

Tablet, Film Coated, Extended Release

Route

Oral

Marketing category

NDA · NDA

Labeler

Santarus, Inc.

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

54% 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	1000 mg/1	860975	View
Metformin Hydrochloride	500 mg/1	860975	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet, Film Coated, Extended Release

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

021748

Application type

NDA · New Drug Application

Approval date

June 3, 2005

Sponsor

SANTARUS INC

Products on application

Submissions recorded

Products approved under application 021748.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
021748-001	GLUMETZA	TABLET, EXTENDED RELEASE		METFORMIN HYDROCHLORIDE	Discontinued	AB3	RLD
021748-002	GLUMETZA	TABLET, EXTENDED RELEASE		METFORMIN HYDROCHLORIDE	Discontinued	AB3	RLD

Therapeutic equivalence

Source: Orange Book

TE code

AB3

Reference Listed Drug

Yes

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 021748.
Type	No.	Action	Status	Date	Review
Supplement	31	Labeling	Approved	August 11, 2026	901 Required
Supplement	25	Labeling	Approved	November 7, 2018	Standard
Supplement	20	Labeling	Approved	April 5, 2017	901 Required
Supplement	19	Manufacturing (CMC)	Approved	October 27, 2015	Standard
Supplement	10	Labeling	Approved	April 13, 2011	Standard
Supplement	8	Labeling	Approved	February 25, 2010	Standard
Supplement	5	Labeling	Approved	June 16, 2009	Standard
Supplement	4	Manufacturing (CMC)	Approved	December 28, 2007	N/A
Supplement	2	Labeling	Approved	November 1, 2006	Standard
Original application	1	Type 5 - New Formulation or New Manufacturer	Approved	June 3, 2005	Standard

Review documents

0 · Supplement · August 18, 2026
0 · Supplement · August 14, 2026
0 · Supplement · November 15, 2018
0 · Supplement · November 9, 2018
0 · Supplement · April 11, 2017
0 · Supplement · April 19, 2011
0 · Supplement · April 15, 2011
0 · Supplement · March 3, 2010
0 · Supplement · June 23, 2009
0 · Supplement · June 22, 2009
0 · Supplement · November 6, 2006
0 · Supplement · November 6, 2006
0 · Original application · September 7, 2006
0 · Original application · June 7, 2005
0 · Original application · June 7, 2005

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.

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
68012-002-13	68012-002	Santarus, Inc.	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-002-13)	August 1, 2006
68012-003-16	68012-003	Santarus, Inc.	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-003-16)	June 17, 2008
68012-004-50	68012-004	Santarus, Inc.	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-004-50)	March 20, 2018
68012-002	68012-002	Santarus, Inc.	—	August 1, 2006
68012-003	68012-003	Santarus, Inc.	—	June 17, 2008
68012-004	68012-004	Santarus, Inc.	—	March 20, 2018

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

Generated September 25, 2026 · 10 sections on this page.