FDA.reportPublic FDA data

Application 076716

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDETABLET;ORAL1.25MG;250MGNoNo
002GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;500MGNoNo
003GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDETABLET;ORAL5MG;500MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076716-001GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2005-06-28
A076716-002GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2005-06-28
A076716-003GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2005-06-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A076716-001AB
A076716-002AB
A076716-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076716-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2005-06-2884e616aacf4f…
2026-09-14 22:38:342026-08A076716-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2005-06-2884e616aacf4f…
2026-09-14 22:38:342026-08A076716-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2005-06-2884e616aacf4f…
2026-08-18 06:07:402026-07A076716-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2005-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A076716-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2005-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A076716-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2005-06-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076716-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2005-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076716-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2005-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076716-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2005-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076716-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2005-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076716-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2005-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076716-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2005-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076716-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2005-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076716-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2005-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076716-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2005-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076716-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2005-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076716-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2005-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076716-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2005-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076716-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2005-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076716-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2005-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076716-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2005-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076716-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2005-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076716-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2005-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076716-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2005-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076716-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2005-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076716-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2005-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076716-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2005-06-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076716-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2005-06-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076716-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2005-06-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076716-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2005-06-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076716-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2005-06-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076716-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2005-06-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076716-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2005-06-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076716-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2005-06-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A076716-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2005-06-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A076716-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2005-06-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076716-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2005-06-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076716-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2005-06-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076716-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2005-06-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076716-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2005-06-28301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-14 00:12 UTC2019-12A076716-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076716-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076716-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076716-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076716-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076716-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076716-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076716-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076716-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076716-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076716-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A076716-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A076716-003AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076716-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A076716-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A076716-003AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076716-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076716-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076716-003AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076716-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076716-002AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076716-003AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076716-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076716-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076716-003AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076716-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076716-002AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076716-003AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076716-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A076716-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A076716-003AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076716-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A076716-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A076716-003AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076716-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076716-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076716-003AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076716-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A076716-002AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A076716-003AB1f41ea6bd6efb…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEBryant Ranch Prepack4dcef36f-000e-43f5-8d67-0e2a079ab2c62026-08-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Glyburide and Metformin Hydrochloride
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDERising Pharma Holdings, Inc.372af566-d6ec-446f-88db-0b4cc83b577f2026-07-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Glyburide and Metformin Hydrochloride
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEAurobindo Pharma Limited7010b662-8b34-49ce-8e5b-73dee0821a602026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Glyburide and Metformin Hydrochloride
glyburide and metformin hydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.2239742b-74e1-4bc2-b5a8-15c4758d6f7b2026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: glyburide and metformin hydrochloride
glyburide and metformin hydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limiteddf752bd4-e197-40a4-a01b-d48ba2c105162026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: glyburide and metformin hydrochloride
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.a58ff524-e975-4d51-a896-e869f8ea66242026-05-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Glyburide and Metformin Hydrochloride
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.c284c146-436b-4eea-9dca-d7d21c82778c2026-05-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Glyburide and Metformin Hydrochloride
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsd87dade1-55fe-4e77-91b9-b642022a2b8a2026-02-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Glyburide and Metformin Hydrochloride
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDENorthwind Health Company, LLCadb751e0-19f6-3f41-e053-2a95a90a2df82026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Glyburide and Metformin Hydrochloride
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.d2b109e4-b743-4c5b-98fa-8e1ff4491dd02025-06-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Glyburide and Metformin Hydrochloride
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.7facb5ac-c1d5-43b4-e053-2991aa0a2a7b2024-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Glyburide and Metformin Hydrochloride
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEBryant Ranch Prepack8f2951ab-20c3-4216-b250-4c6a62d322032024-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: 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 listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1648Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideImpax GenericsANDACurrent
0115-1649Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideImpax GenericsANDACurrent
0115-1650Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideImpax GenericsANDACurrent
0228-2751Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2751Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2751Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2751Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2752Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2752Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2752Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2752Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2753Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2753Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2753Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2753Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
43063-397Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
67544-511Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
68788-9128Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent