Home NDC 0093-8034-99 Glyburide
Product NDC 0093-8034
Requested package NDC 0093-8034-99
11-digit product format 000938034
Labeler code 0093
Product ID 0093-8034_d734cd0e-df7b-40a2-a511-fc04308a764d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glyburide
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA074686
Marketing category ANDA
Marketing start 1999-05-11
Marketing end 2026-07-31
Substance GLYBURIDE
Active strength 1.5 mg/1
Pharmacologic classes Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074686-001 GLYBURIDE (MICRONIZED) GLYBURIDE 1.5MG TABLET / ORAL 1999-04-20 A074686-002 GLYBURIDE (MICRONIZED) GLYBURIDE 3MG TABLET / ORAL 1999-04-20 A074686-003 GLYBURIDE (MICRONIZED) GLYBURIDE 4.5MG TABLET / ORAL 1999-04-20 A074686-004 GLYBURIDE (MICRONIZED) GLYBURIDE 6MG TABLET / ORAL RS 1999-04-20
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 5 · 164 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 2026-02-19 14:30 UTC 2026-02 A074686-001 GLYBURIDE (MICRONIZED) 1.5MG TABLET / ORAL 1999-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074686-002 GLYBURIDE (MICRONIZED) 3MG TABLET / ORAL 1999-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074686-003 GLYBURIDE (MICRONIZED) 4.5MG TABLET / ORAL 1999-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074686-004 GLYBURIDE (MICRONIZED) 6MG TABLET / ORAL RS 1999-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074686-001 GLYBURIDE (MICRONIZED) 1.5MG TABLET / ORAL 1999-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074686-002 GLYBURIDE (MICRONIZED) 3MG TABLET / ORAL 1999-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074686-003 GLYBURIDE (MICRONIZED) 4.5MG TABLET / ORAL 1999-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074686-004 GLYBURIDE (MICRONIZED) 6MG TABLET / ORAL RS 1999-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074686-001 GLYBURIDE (MICRONIZED) 1.5MG TABLET / ORAL AB 1999-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074686-002 GLYBURIDE (MICRONIZED) 3MG TABLET / ORAL AB 1999-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074686-003 GLYBURIDE (MICRONIZED) 4.5MG TABLET / ORAL 1999-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074686-004 GLYBURIDE (MICRONIZED) 6MG TABLET / ORAL AB 1999-04-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074686-001 GLYBURIDE (MICRONIZED) 1.5MG TABLET / ORAL AB 1999-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074686-002 GLYBURIDE (MICRONIZED) 3MG TABLET / ORAL AB 1999-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074686-003 GLYBURIDE (MICRONIZED) 4.5MG TABLET / ORAL 1999-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074686-004 GLYBURIDE (MICRONIZED) 6MG TABLET / ORAL AB 1999-04-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074686-001 GLYBURIDE (MICRONIZED) 1.5MG TABLET / ORAL AB 1999-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074686-002 GLYBURIDE (MICRONIZED) 3MG TABLET / ORAL AB 1999-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074686-003 GLYBURIDE (MICRONIZED) 4.5MG TABLET / ORAL 1999-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074686-004 GLYBURIDE (MICRONIZED) 6MG TABLET / ORAL AB 1999-04-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074686-001 GLYBURIDE (MICRONIZED) 1.5MG TABLET / ORAL AB 1999-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074686-002 GLYBURIDE (MICRONIZED) 3MG TABLET / ORAL AB 1999-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074686-003 GLYBURIDE (MICRONIZED) 4.5MG TABLET / ORAL 1999-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074686-004 GLYBURIDE (MICRONIZED) 6MG TABLET / ORAL AB 1999-04-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074686-001 GLYBURIDE (MICRONIZED) 1.5MG TABLET / ORAL AB 1999-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074686-002 GLYBURIDE (MICRONIZED) 3MG TABLET / ORAL AB 1999-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074686-003 GLYBURIDE (MICRONIZED) 4.5MG TABLET / ORAL 1999-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074686-004 GLYBURIDE (MICRONIZED) 6MG TABLET / ORAL AB 1999-04-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074686-001 GLYBURIDE (MICRONIZED) 1.5MG TABLET / ORAL AB 1999-04-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074686-002 GLYBURIDE (MICRONIZED) 3MG TABLET / ORAL AB 1999-04-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074686-003 GLYBURIDE (MICRONIZED) 4.5MG TABLET / ORAL 1999-04-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074686-004 GLYBURIDE (MICRONIZED) 6MG TABLET / ORAL AB 1999-04-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074686-001 GLYBURIDE (MICRONIZED) 1.5MG TABLET / ORAL AB 1999-04-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074686-002 GLYBURIDE (MICRONIZED) 3MG TABLET / ORAL AB 1999-04-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074686-003 GLYBURIDE (MICRONIZED) 4.5MG TABLET / ORAL 1999-04-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074686-004 GLYBURIDE (MICRONIZED) 6MG TABLET / ORAL AB 1999-04-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074686-001 GLYBURIDE (MICRONIZED) 1.5MG TABLET / ORAL AB 1999-04-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074686-002 GLYBURIDE (MICRONIZED) 3MG TABLET / ORAL AB 1999-04-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074686-003 GLYBURIDE (MICRONIZED) 4.5MG TABLET / ORAL 1999-04-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074686-004 GLYBURIDE (MICRONIZED) 6MG TABLET / ORAL AB 1999-04-20 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 119 observed states.
Additional Listing Data#
Finished product No
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYBURIDE 1.5 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0093-8034-01 Glyburide 100 in 1 BOTTLE TABLET 100 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GLYBURIDE ACTIVE INGREDIENT SX6K58TVWC GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC] 11 GLYBURIDE ACTIVE MOIETY SX6K58TVWC GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC] 11 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC] 11 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC] 11 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC] 11 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC] 11 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC] 11 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC] 11 GLYBURIDE ACTIVE INGREDIENT SX6K58TVWC GLYBURIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 GLYBURIDE ACTIVE MOIETY SX6K58TVWC GLYBURIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GLYBURIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 GLYBURIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD GLYBURIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK GLYBURIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GLYBURIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 GLYBURIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ GLYBURIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-8034 GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA, INC.] 15 Current NDC, Legacy NDC, 1 package rows 20230913_e84c0dfc-a4e9-4c89-b6ea-45732eb412f5.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Status 0093-8034-99 00093803499 85714 TABLET in 1 PAIL (0093-8034-99) 85714 tablet 27-JUL-23 Current