Application 076257

Type: ANDA
Sponsor: EPIC PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLYBURIDE	GLYBURIDE	TABLET;ORAL	1.25MG	No	No
002	GLYBURIDE	GLYBURIDE	TABLET;ORAL	2.5MG	No	No
003	GLYBURIDE	GLYBURIDE	TABLET;ORAL	5MG	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076257-001	GLYBURIDE	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2002-06-27
A076257-002	GLYBURIDE	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2002-06-27
A076257-003	GLYBURIDE	GLYBURIDE	5MG	TABLET / ORAL	AB1	2002-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076257-001	AB1
A076257-002	AB1
A076257-003	AB1

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076257-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2002-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076257-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2002-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076257-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2002-06-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076257-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2002-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076257-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2002-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076257-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2002-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076257-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2002-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076257-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2002-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076257-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2002-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076257-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2002-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076257-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2002-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076257-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2002-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076257-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2002-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076257-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2002-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076257-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2002-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076257-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2002-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076257-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2002-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076257-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2002-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076257-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2002-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076257-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2002-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076257-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2002-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076257-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2002-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076257-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2002-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076257-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2002-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076257-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2002-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076257-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2002-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076257-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2002-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076257-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2002-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076257-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2002-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076257-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2002-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076257-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2002-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076257-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2002-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076257-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2002-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076257-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2002-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076257-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2002-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076257-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2002-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076257-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2002-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076257-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2002-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076257-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2002-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076257-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2002-06-27	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076257-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076257-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076257-003	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076257-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076257-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076257-003	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076257-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076257-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076257-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076257-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076257-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076257-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076257-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076257-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076257-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076257-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076257-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076257-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076257-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076257-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076257-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076257-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076257-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076257-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076257-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076257-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076257-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076257-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076257-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076257-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076257-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076257-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076257-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076257-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076257-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076257-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076257-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076257-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076257-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076257-001	AB1	1	`301d65b070ca…`

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 2 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GLYBURIDE	GLYBURIDE	NuCare Pharmaceuticals,Inc.	a12342fb-123c-2951-e053-2a95a90ac596	2024-06-20	Adverse reactions	Name fallback brand name: GLYBURIDE generic name: GLYBURIDE
GLYBURIDE	GLYBURIDE	NuCare Pharmaceuticals,Inc.	a1233548-bbb8-34aa-e053-2a95a90aea53	2024-06-20	Adverse reactions	Name fallback brand name: GLYBURIDE generic name: GLYBURIDE
Glyburide	GLYBURIDE	NuCare Pharmaceuticals,Inc.	901c50d5-31e7-b073-e053-2995a90abfeb	2024-06-19	Adverse reactions	Name fallback brand name: Glyburide generic name: GLYBURIDE
Glyburide	GLYBURIDE	A-S Medication Solutions	d090f978-b1a5-4db7-951d-3f32dd06966c	2024-01-02	Warnings, Adverse reactions	Name fallback brand name: Glyburide generic name: GLYBURIDE
GLYBURIDE	GLYBURIDE	A-S Medication Solutions	7a280f88-26d4-4fe5-a89b-a6f1d90ed3cd	2023-12-03	Adverse reactions	Name fallback brand name: GLYBURIDE generic name: GLYBURIDE
Glyburide	GLYBURIDE	A-S Medication Solutions	922d1080-52c6-41e4-a310-533d8ca18594	2023-08-28	Warnings, Adverse reactions	Name fallback brand name: Glyburide generic name: GLYBURIDE
GLYBURIDE	GLYBURIDE	A-S Medication Solutions	3c91a408-973b-4572-832f-515f61d5be1f	2023-02-04	Adverse reactions	Name fallback brand name: GLYBURIDE generic name: GLYBURIDE
Glyburide	GLYBURIDE	Teva Pharmaceuticals USA, Inc.	e84c0dfc-a4e9-4c89-b6ea-45732eb412f5	2023-01-09	Warnings, Adverse reactions	Name fallback brand name: Glyburide generic name: GLYBURIDE
Glyburide	GLYBURIDE	Cadila Pharmaceuticals Limited	ea7a055b-64f0-46bf-aa8e-4a2ef5c3c035	2022-12-29	Warnings, Adverse reactions	Name fallback brand name: Glyburide generic name: GLYBURIDE
Glyburide	GLYBURIDE	Modavar Pharmaceuticals LLC	a5de0ef6-4c8b-40ab-b0ed-2003a8086750	2022-12-29	Warnings, Adverse reactions	Name fallback brand name: Glyburide generic name: GLYBURIDE
glyburide	GLYBURIDE	Zydus Lifesciences Limited	5d0e406f-285d-4716-8971-82f665345517	2022-11-16	Adverse reactions	Name fallback brand name: glyburide generic name: GLYBURIDE
glyburide	GLYBURIDE	Zydus Pharmaceuticals (USA) Inc.	87781ea8-62ec-483c-a4dd-8c965ce59485	2022-11-16	Adverse reactions	Name fallback brand name: glyburide generic name: GLYBURIDE
Glyburide	GLYBURIDE	TEVA Pharmaceuticals USA Inc	50d16f1d-c814-4411-8749-62561321ecce	2021-07-01	Warnings, Adverse reactions	Name fallback brand name: Glyburide generic name: GLYBURIDE
Glyburide	GLYBURIDE	Proficient Rx LP	ec45f0d8-cab8-4822-895b-17bb443a4f98	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Glyburide generic name: GLYBURIDE
Glyburide	GLYBURIDE	Proficient Rx LP	b292cb9b-7348-4c07-a871-bc091229fdf8	2019-11-01	Adverse reactions	Name fallback brand name: Glyburide generic name: GLYBURIDE
Glyburide	GLYBURIDE	Proficient Rx LP	240c3ac6-9aab-4185-994e-a0254e3aeb61	2019-11-01	Adverse reactions	Name fallback brand name: Glyburide generic name: GLYBURIDE
Glyburide	GLYBURIDE	Teva Pharmaceuticals USA, Inc.	a56f100f-0f42-4188-81ab-04644b824040	2015-05-31	Warnings, Adverse reactions	Name fallback brand name: Glyburide generic name: GLYBURIDE

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-467	Glyburide	Glyburide	Rebel Distributors Corp	ANDA	Current
21695-468	Glyburide	Glyburide	Rebel Distributors Corp	ANDA	Current
67046-240	Glyburide	Glyburide	Contract Pharmacy Services-PA	ANDA	Current