Glimepiride

Product NDC
70934-167
11-digit product format
709340167
Labeler code
70934
Product ID
70934-167_b8df8208-8209-72a9-e053-2a95a90ae5cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA078181
Marketing category
ANDA
Marketing start
2018-09-10
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
2 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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70934-167IInactivated by FDA2026-08-03
excluded packagepackage70934-16770934-167-30IInactivated by FDA2026-08-03
excluded packagepackage70934-16770934-167-90IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 6 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct70934-167IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70934-16770934-167-90IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70934-16770934-167-30IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct70934-167IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70934-16770934-167-90IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70934-16770934-167-30IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-238072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078181-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078181-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078181-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078181-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078181-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078181-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078181-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078181-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078181-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078181-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078181-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078181-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078181-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078181-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078181-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078181-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078181-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078181-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078181-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078181-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078181-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078181-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078181-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078181-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078181-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078181-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078181-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078181-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078181-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078181-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078181-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078181-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078181-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078181-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078181-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078181-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078181-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078181-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078181-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078181-001AB18072bd15b7f6…

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b890b964-2cf0-4439-aaf3-900c9e3e9e49Product name120160602
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
d36d861f-8a90-80cc-8935-1e6be9b4c7ebProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-167-302023-01-30C16284748780-1ba0f9c33-5a00-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 USP for oral use Initial U.S. Approval: 1995
70934-167-902023-01-30C16284748780-1ba0f9c33-5a00-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 USP for oral use Initial U.S. Approval: 1995
70934-167-302021-01-31C16284748780-1ba0f9c33-5a00-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 USP for oral use Initial U.S. Approval: 1995
70934-167-902021-01-31C16284748780-1ba0f9c33-5a00-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 USP for oral use Initial U.S. Approval: 1995
70934-167-302021-01-29C16284748780-1ba0f9c33-5a00-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 USP for oral use Initial U.S. Approval: 1995
70934-167-902021-01-29C16284748780-1ba0f9c33-5a00-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 USP for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-167-30Glimepiride30 in 1 BOTTLE, PLASTICTABLET303
70934-167-90Glimepiride90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-167-30EA - Each70934-1676658a301-5f40-4e36-8523-d9bf0bcf495b12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-167GLIMEPIRIDE TABLET [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]3Legacy NDC, 2 package rows20210201_77e5e09e-4117-3136-e053-2991aa0a9379.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSN77e5e09e-4117-3136-e053-2991aa0a93793
199246glimepiride 2 MG Oral TabletSCD77e5e09e-4117-3136-e053-2991aa0a93793

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-167-307093401673030 TABLET in 1 BOTTLE, PLASTIC (70934-167-30) 30 tablet2018-09-100000-00-00NoNoCurrent
70934-167-907093401679090 TABLET in 1 BOTTLE, PLASTIC (70934-167-90) 90 tablet2019-06-050000-00-00NoNoCurrent