Home NDC 0093-7254 Glimepiride
Product NDC 0093-7254
11-digit product format 000937254
Labeler code 0093
Product ID 0093-7254_909c8f8e-3578-4742-99c5-3895d715d7f0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glimepiride
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA076802
Marketing category ANDA
Marketing start 2005-10-06
Marketing end 2020-04-30
Substance GLIMEPIRIDE
Active strength 1 mg/1
Pharmacologic classes Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0093-7254-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0093-7254-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0093-7254-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0093-7254-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0093-7254-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0093-7254-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0093-7254-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0093-7254-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0093-7254-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0093-7254-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0093-7254-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0093-7254-01 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076802-001 GLIMEPIRIDE GLIMEPIRIDE 1MG TABLET / ORAL 2005-10-06 A076802-002 GLIMEPIRIDE GLIMEPIRIDE 2MG TABLET / ORAL 2005-10-06 A076802-003 GLIMEPIRIDE GLIMEPIRIDE 4MG TABLET / ORAL 2005-10-06
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.
Product history page 1 of 4 · 126 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A076802-001 GLIMEPIRIDE 1MG TABLET / ORAL 2005-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076802-002 GLIMEPIRIDE 2MG TABLET / ORAL 2005-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076802-003 GLIMEPIRIDE 4MG TABLET / ORAL 2005-10-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076802-001 GLIMEPIRIDE 1MG TABLET / ORAL 2005-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076802-002 GLIMEPIRIDE 2MG TABLET / ORAL 2005-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076802-003 GLIMEPIRIDE 4MG TABLET / ORAL 2005-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076802-001 GLIMEPIRIDE 1MG TABLET / ORAL 2005-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076802-002 GLIMEPIRIDE 2MG TABLET / ORAL 2005-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076802-003 GLIMEPIRIDE 4MG TABLET / ORAL 2005-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076802-001 GLIMEPIRIDE 1MG TABLET / ORAL 2005-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076802-002 GLIMEPIRIDE 2MG TABLET / ORAL 2005-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076802-003 GLIMEPIRIDE 4MG TABLET / ORAL 2005-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076802-001 GLIMEPIRIDE 1MG TABLET / ORAL 2005-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076802-002 GLIMEPIRIDE 2MG TABLET / ORAL 2005-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076802-003 GLIMEPIRIDE 4MG TABLET / ORAL 2005-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076802-001 GLIMEPIRIDE 1MG TABLET / ORAL 2005-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076802-002 GLIMEPIRIDE 2MG TABLET / ORAL 2005-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076802-003 GLIMEPIRIDE 4MG TABLET / ORAL 2005-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076802-001 GLIMEPIRIDE 1MG TABLET / ORAL 2005-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076802-002 GLIMEPIRIDE 2MG TABLET / ORAL 2005-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076802-003 GLIMEPIRIDE 4MG TABLET / ORAL 2005-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076802-001 GLIMEPIRIDE 1MG TABLET / ORAL 2005-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076802-002 GLIMEPIRIDE 2MG TABLET / ORAL 2005-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076802-003 GLIMEPIRIDE 4MG TABLET / ORAL 2005-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076802-001 GLIMEPIRIDE 1MG TABLET / ORAL 2005-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076802-002 GLIMEPIRIDE 2MG TABLET / ORAL 2005-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076802-003 GLIMEPIRIDE 4MG TABLET / ORAL 2005-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076802-001 GLIMEPIRIDE 1MG TABLET / ORAL 2005-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076802-002 GLIMEPIRIDE 2MG TABLET / ORAL 2005-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076802-003 GLIMEPIRIDE 4MG TABLET / ORAL 2005-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076802-001 GLIMEPIRIDE 1MG TABLET / ORAL 2005-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076802-002 GLIMEPIRIDE 2MG TABLET / ORAL 2005-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076802-003 GLIMEPIRIDE 4MG TABLET / ORAL 2005-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076802-001 GLIMEPIRIDE 1MG TABLET / ORAL 2005-10-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076802-002 GLIMEPIRIDE 2MG TABLET / ORAL 2005-10-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076802-003 GLIMEPIRIDE 4MG TABLET / ORAL 2005-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076802-001 GLIMEPIRIDE 1MG TABLET / ORAL 2005-10-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076802-002 GLIMEPIRIDE 2MG TABLET / ORAL 2005-10-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076802-003 GLIMEPIRIDE 4MG TABLET / ORAL 2005-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076802-001 GLIMEPIRIDE 1MG TABLET / ORAL 2005-10-06 1e350fbaab3a…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GLIMEPIRIDE ACTIVE INGREDIENT 6KY687524K GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC] 9 GLIMEPIRIDE ACTIVE MOIETY 6KY687524K GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC] 9 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC] 9 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC] 9 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC] 9 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC] 9 INDIGOTINDISULFONATE SODIUM INACTIVE INGREDIENT D3741U8K7L GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC] 9 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC] 9 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC] 9 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC] 9 GLIMEPIRIDE ACTIVE INGREDIENT 6KY687524K GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 GLIMEPIRIDE ACTIVE MOIETY 6KY687524K GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed RxNorm Mappings#