FDA.reportPublic FDA data

Glimepiride

Product NDC
68071-3068
11-digit product format
680713068
Labeler code
68071
Product ID
68071-3068_bb12d6b2-db7e-ae56-e053-2a95a90ab820
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA078181
Marketing category
ANDA
Marketing start
2007-08-23
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
1 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-3068DDiscontinued by firm2026-07-31
excluded packagepackage68071-306868071-3068-3DDiscontinued by firm2026-07-31
excluded packagepackage68071-306868071-3068-6DDiscontinued by firm2026-07-31
excluded packagepackage68071-306868071-3068-9DDiscontinued 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
A078181-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORALAB2007-08-23
A078181-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORALAB2007-08-23
A078181-003GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORALAB2007-08-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A078181-001AB
A078181-002AB
A078181-003AB

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 22:54:322026-06A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23a50c72e98297…
2026-08-01 22:54:322026-06A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23a50c72e98297…
2026-08-01 22:54:322026-06A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078181-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078181-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078181-003AB1a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDEBryant Ranch Prepack9e863f84-d6f2-4d61-8250-774569e843532026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.58c4261e-e98f-4280-9562-2800956dff142026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.1b3c7d74-f80b-4fb1-8dca-66880af5d3fc2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDENorthwind Health Company, LLC3e81a39a-30bb-4d6d-82e1-17d7134365be2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDENorthwind Health Company, LLCf2f2d6da-eb40-4290-e053-2a95a90a6ca02026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEAccord Healthcare Inc9b74fbac-9e04-4927-9981-1e3dace89c6d2025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEProficient Rx LPbeb0cefb-807b-4cc3-ada2-7a8ed4aa8f2b2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEProficient Rx LP5a5747ea-cded-49ed-8807-dd3e2a1159e02022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEProficient Rx LP68cb4fcd-5bc3-4f53-9085-86df6a4246d62022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3068-32024-08-15C16284748780-1ba0f9c33-4e7a-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995
68071-3068-62024-08-15C16284748780-1ba0f9c33-4e7a-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995
68071-3068-92024-08-15C16284748780-1ba0f9c33-4e7a-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995
68071-3068-32023-01-30C16284748780-1ba0f9c33-4e7a-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995
68071-3068-62023-01-30C16284748780-1ba0f9c33-4e7a-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995
68071-3068-92023-01-30C16284748780-1ba0f9c33-4e7a-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995
68071-3068-32021-02-11C16284748780-1ba0f9c33-4e7a-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995
68071-3068-62021-02-11C16284748780-1ba0f9c33-4e7a-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995
68071-3068-92021-02-11C16284748780-1ba0f9c33-4e7a-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995
68071-3068-32021-01-29C16284748780-1ba0f9c33-4e7a-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995
68071-3068-62021-01-29C16284748780-1ba0f9c33-4e7a-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995
68071-3068-92021-01-29C16284748780-1ba0f9c33-4e7a-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3068-36807130680330 TABLET in 1 BOTTLE (68071-3068-3) 30 tablet2017-03-090000-00-00NoNoCurrent
68071-3068-66807130680660 TABLET in 1 BOTTLE (68071-3068-6) 60 tablet2017-03-090000-00-00NoNoCurrent
68071-3068-96807130680990 TABLET in 1 BOTTLE (68071-3068-9) 90 tablet2017-03-090000-00-00NoNoCurrent