Application 076345
- Type
- ANDA
- Sponsor
- IMPAX LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 1.25MG;250MG | No | No |
| 002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 2.5MG;500MG | No | No |
| 003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 5MG;500MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076345-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2004-02-18 | |
| A076345-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | |
| A076345-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2004-02-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076345-001 | AB |
| A076345-002 | AB |
| A076345-003 | AB |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076345-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2004-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076345-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076345-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A076345-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2004-02-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076345-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076345-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076345-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2004-02-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076345-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076345-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076345-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2004-02-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076345-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076345-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076345-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2004-02-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076345-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076345-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076345-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2004-02-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076345-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076345-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076345-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2004-02-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076345-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076345-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076345-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2004-02-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076345-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076345-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076345-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2004-02-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076345-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076345-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076345-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2004-02-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076345-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076345-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076345-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2004-02-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076345-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076345-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076345-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2004-02-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076345-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076345-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076345-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2004-02-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076345-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076345-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2004-02-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076345-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2004-02-18 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076345-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076345-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076345-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076345-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076345-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076345-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A076345-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A076345-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076345-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076345-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076345-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076345-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A076345-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A076345-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076345-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A076345-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A076345-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076345-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076345-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076345-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A076345-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A076345-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A076345-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A076345-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A076345-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A076345-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076345-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076345-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076345-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A076345-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A076345-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A076345-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A076345-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A076345-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A076345-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A076345-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A076345-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A076345-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A076345-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076345-002 | AB | 1 | 3f01610625f2… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Glyburide and Metformin Hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 4dcef36f-000e-43f5-8d67-0e2a079ab2c6 | 2026-08-18 | Boxed warning, Warnings, Adverse reactions | Glyburide and Metformin Hydrochloride |
| Glyburide and Metformin Hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 372af566-d6ec-446f-88db-0b4cc83b577f | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | Glyburide and Metformin Hydrochloride |
| Glyburide and Metformin Hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | 7010b662-8b34-49ce-8e5b-73dee0821a60 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | Glyburide and Metformin Hydrochloride |
| glyburide and metformin hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | 2239742b-74e1-4bc2-b5a8-15c4758d6f7b | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | glyburide and metformin hydrochloride |
| glyburide and metformin hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | Zydus Lifesciences Limited | df752bd4-e197-40a4-a01b-d48ba2c10516 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | glyburide and metformin hydrochloride |
| Glyburide and Metformin Hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | a58ff524-e975-4d51-a896-e869f8ea6624 | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | Glyburide and Metformin Hydrochloride |
| Glyburide and Metformin Hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | c284c146-436b-4eea-9dca-d7d21c82778c | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | Glyburide and Metformin Hydrochloride |
| Glyburide and Metformin Hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | A-S Medication Solutions | d87dade1-55fe-4e77-91b9-b642022a2b8a | 2026-02-08 | Boxed warning, Warnings, Adverse reactions | Glyburide and Metformin Hydrochloride |
| Glyburide and Metformin Hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | adb751e0-19f6-3f41-e053-2a95a90a2df8 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Glyburide and Metformin Hydrochloride |
| Glyburide and Metformin Hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | d2b109e4-b743-4c5b-98fa-8e1ff4491dd0 | 2025-06-16 | Boxed warning, Warnings, Adverse reactions | Glyburide and Metformin Hydrochloride |
| Glyburide and Metformin Hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 7facb5ac-c1d5-43b4-e053-2991aa0a2a7b | 2024-06-12 | Boxed warning, Warnings, Adverse reactions | Glyburide and Metformin Hydrochloride |
| Glyburide and Metformin Hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 8f2951ab-20c3-4216-b250-4c6a62d32203 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | Glyburide and Metformin Hydrochloride |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-568 | Glyburide and Metformin | Glyburide and Metformin | Rebel Distributors Corp | ANDA | Current |
| 42254-071 | Glyburide and Metformin | Glyburide and Metformin | Rebel Distributors Corp | ANDA | Current |
| 45865-710 | Glyburide and Metformin Hydrochloride | Glyburide and Metformin Hydrochloride | Medsource Pharmaceuticals | ANDA | Current |
| 63629-3998 | Glyburide and Metformin | Glyburide and Metformin | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8897 | ORIG | 2004-02-27 |