Home NDC 0093-7256 Glimepiride
Product NDC 0093-7256
11-digit product format 000937256
Labeler code 0093
Product ID 0093-7256_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 2020-08-31
Substance GLIMEPIRIDE
Active strength 4 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 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-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.
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 2026-08-01 22:54:32 2026-06 A076802-001 GLIMEPIRIDE 1MG TABLET / ORAL 2005-10-06 a50c72e98297…2026-08-01 22:54:32 2026-06 A076802-002 GLIMEPIRIDE 2MG TABLET / ORAL 2005-10-06 a50c72e98297…2026-08-01 22:54:32 2026-06 A076802-003 GLIMEPIRIDE 4MG TABLET / ORAL 2005-10-06 a50c72e98297…
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#