FDA.reportPublic FDA data

Glumetza

Product NDC
13913-002
11-digit product format
139130002
Labeler code
13913
Product ID
13913-002_121fc3e0-33fe-41af-a7ef-e6b54ee60ef6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metformin hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Depomed, Inc.
Application
NDA021748
Marketing category
NDA
Marketing start
2006-08-01
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC],Biguanides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct13913-002DDiscontinued by firm2026-07-31
excluded packagepackage13913-00213913-002-13DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021748-001GLUMETZAMETFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALRLD2005-06-03
N021748-002GLUMETZAMETFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALRLD2005-06-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021748-001GLUMETZA500MGTABLET, EXTENDED RELEASE / ORALRLD2005-06-03a50c72e98297…
2026-08-01 22:54:322026-06N021748-002GLUMETZA1GMTABLET, EXTENDED RELEASE / ORALRLD2005-06-03a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin hydrochlorideMETFORMIN HYDROCHLORIDEOceanside Pharmaceuticals74d32a8a-c4c2-4dbb-b376-eea3f8fa64d72024-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021748
application number: NDA021748
GlumetzaMETFORMIN HYDROCHLORIDESantarus, Inc.fb832474-88d9-4e29-95cd-fbc446944cc42024-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021748
application number: NDA021748

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13913-002-132023-02-16C16284748780-1960f7f55-d463-8e05-e053-dbdaa90a074aThese highlights do not include all the information needed to use GLUMETZA safely and effectively. See full prescribing information for GLUMETZA. GLUMETZA ® (metformin hydrochloride extended-release tablets), 500 mg and 1000 mg Initial U.S. Approval: 1995
13913-002-132019-10-29C16284748780-1960f7f55-d463-8e05-e053-dbdaa90a074aThese highlights do not include all the information needed to use GLUMETZA safely and effectively. See full prescribing information for GLUMETZA. GLUMETZA ® (metformin hydrochloride extended-release tablets), 500 mg and 1000 mg Initial U.S. Approval: 1995

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EGLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]14
METFORMINACTIVE MOIETY9100L32L2NGLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]14
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]14
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]14
GLYCERYL BEHENATEINACTIVE INGREDIENTR8WTH25YS2GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]14
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]14
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AGLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]14
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]14
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]14
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]14
TALCINACTIVE INGREDIENT7SEV7J4R1UGLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]14
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]14