Application 077870
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA
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 | Yes |
| 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 |
|---|---|---|---|---|---|---|---|
| A077870-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2007-11-14 | |
| A077870-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | RS | 2007-11-14 |
| A077870-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2007-11-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077870-001 | AB |
| A077870-002 | AB |
| A077870-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077870-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2007-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077870-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | RS | 2007-11-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077870-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2007-11-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077870-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2007-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077870-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | RS | 2007-11-14 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077870-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2007-11-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077870-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2007-11-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077870-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | RS | 2007-11-14 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077870-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2007-11-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077870-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2007-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077870-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | RS | 2007-11-14 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077870-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2007-11-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077870-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2007-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077870-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | RS | 2007-11-14 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077870-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2007-11-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077870-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2007-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077870-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | RS | 2007-11-14 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077870-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2007-11-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077870-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2007-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077870-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | RS | 2007-11-14 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077870-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2007-11-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077870-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2007-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077870-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | RS | 2007-11-14 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077870-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2007-11-14 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077870-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2007-11-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077870-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | RS | 2007-11-14 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077870-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2007-11-14 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077870-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2007-11-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077870-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | RS | 2007-11-14 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077870-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2007-11-14 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077870-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2007-11-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077870-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | RS | 2007-11-14 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077870-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2007-11-14 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077870-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2007-11-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077870-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | RS | 2007-11-14 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077870-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2007-11-14 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077870-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2007-11-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077870-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | RS | 2007-11-14 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077870-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2007-11-14 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077870-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET / ORAL | AB | 2007-11-14 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077870-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077870-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077870-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077870-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077870-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077870-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077870-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077870-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077870-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077870-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077870-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077870-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077870-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077870-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077870-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077870-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077870-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077870-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077870-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077870-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077870-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077870-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077870-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077870-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077870-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077870-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077870-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077870-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077870-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077870-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077870-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077870-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077870-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077870-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077870-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077870-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077870-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077870-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077870-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077870-001 | AB | 1 | 8072bd15b7f6… |
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 | Rising Pharma Holdings, Inc. | 372af566-d6ec-446f-88db-0b4cc83b577f | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | 077870 ANDA077870 |
| Glyburide and Metformin Hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | 7010b662-8b34-49ce-8e5b-73dee0821a60 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | 077870 ANDA077870 |
| Glyburide and Metformin Hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | a58ff524-e975-4d51-a896-e869f8ea6624 | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | 077870 ANDA077870 |
| Glyburide and Metformin Hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | c284c146-436b-4eea-9dca-d7d21c82778c | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | 077870 ANDA077870 |
| 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 | 077870 ANDA077870 |
| 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 | 077870 ANDA077870 |
| Glyburide and Metformin Hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | d2b109e4-b743-4c5b-98fa-8e1ff4491dd0 | 2025-06-16 | Boxed warning, Warnings, Adverse reactions | 077870 ANDA077870 |
| Glyburide and Metformin Hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 4dcef36f-000e-43f5-8d67-0e2a079ab2c6 | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | 077870 ANDA077870 |
| Glyburide and Metformin Hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 7facb5ac-c1d5-43b4-e053-2991aa0a2a7b | 2024-06-12 | Boxed warning, Warnings, Adverse reactions | 077870 ANDA077870 |
| Glyburide and Metformin Hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 8f2951ab-20c3-4216-b250-4c6a62d32203 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | 077870 ANDA077870 71335-0967 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 71335-0967 | Glyburide and Metformin Hydrochloride | Glyburide and Metformin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0967 | Glyburide and Metformin Hydrochloride | Glyburide and Metformin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0980 | Glyburide and Metformin Hydrochloride | Glyburide and Metformin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0980 | Glyburide and Metformin Hydrochloride | Glyburide and Metformin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 72789-275 | Glyburide and Metformin Hydrochloride | Glyburide and Metformin Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |