FDA.reportPublic FDA data

Glimepiride

Product NDC
42708-083
11-digit product format
427080083
Labeler code
42708
Product ID
42708-083_873949b6-4983-43a0-9233-eb341f331a19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
QPharma Inc
Application
ANDA076802
Marketing category
ANDA
Marketing start
2005-10-06
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
4 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct42708-083DDiscontinued by firm2026-07-31
excluded packagepackage42708-08342708-083-30DDiscontinued 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076802-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORAL2005-10-06
A076802-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORAL2005-10-06
A076802-003GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORAL2005-10-06

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 22:54:322026-06A076802-001GLIMEPIRIDE1MGTABLET / ORAL2005-10-06a50c72e98297…
2026-08-01 22:54:322026-06A076802-002GLIMEPIRIDE2MGTABLET / ORAL2005-10-06a50c72e98297…
2026-08-01 22:54:322026-06A076802-003GLIMEPIRIDE4MGTABLET / ORAL2005-10-06a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42708-083-302021-03-12C16284748780-1ba0f9c33-32ee-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GLIMEPIRIDE TABLETS safely and effectively. See full prescribing information for GLIMEPIRIDE TABLETS. GLIMEPIRIDE tablets, for oral use Initial U.S. Approval: 1995
42708-083-302021-01-29C16284748780-1ba0f9c33-32ee-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GLIMEPIRIDE TABLETS safely and effectively. See full prescribing information for GLIMEPIRIDE TABLETS. GLIMEPIRIDE tablets, for oral use Initial U.S. Approval: 1995