Application 090937

Type: ANDA
Sponsor: HERITAGE PHARMS INC

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 1.

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
A090937-001	GLYBURIDE	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28
A090937-002	GLYBURIDE	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28
A090937-003	GLYBURIDE	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090937-001	AB1
A090937-002	AB1
A090937-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090937-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090937-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090937-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090937-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090937-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090937-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090937-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090937-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090937-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090937-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090937-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090937-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090937-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090937-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090937-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090937-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090937-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090937-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090937-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090937-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090937-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090937-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090937-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090937-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090937-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090937-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090937-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090937-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090937-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090937-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090937-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090937-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090937-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090937-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090937-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090937-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090937-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090937-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090937-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090937-001	AB1	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.

Matched openFDA labels page 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GLYBURIDE	GLYBURIDE	Bryant Ranch Prepack	9cdd30e7-512a-4f00-a4de-0a154d143ce9	2026-05-18	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937 ndc (product): 71335-0069
GLYBURIDE	GLYBURIDE	Northwind Health Company, LLC	d9cb9251-7b31-72a0-e053-2a95a90a4315	2026-01-01	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
GLYBURIDE	GLYBURIDE	Northwind Health Company, LLC	db47a517-f8bb-136f-e053-2a95a90ad8c5	2026-01-01	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
GLYBURIDE	GLYBURIDE	Chartwell RX, LLC	7e661288-2d24-4403-86a1-754afa1d04ff	2025-12-09	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
GLYBURIDE	GLYBURIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	33418bba-c5ea-4c0f-9d28-31dc2724c6c3	2025-10-31	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
Glyburide	GLYBURIDE	NuCare Pharmaceuticals,Inc.	7ee41cd3-461f-3408-e053-2991aa0a863d	2025-02-06	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
GLYBURIDE	GLYBURIDE	Bryant Ranch Prepack	05341afe-5b7a-462a-a196-689cb09f83fc	2025-01-28	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937 ndc (product): 71335-0150
Glyburide	GLYBURIDE	NuCare Pharmaceuticals, Inc.	3e354b4d-70e4-5089-e054-00144ff88e88	2024-08-13	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
GLYBURIDE	GLYBURIDE	NuCare Pharmaceuticals,Inc.	a12342fb-123c-2951-e053-2a95a90ac596	2024-06-20	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
GLYBURIDE	GLYBURIDE	NuCare Pharmaceuticals,Inc.	a1233548-bbb8-34aa-e053-2a95a90aea53	2024-06-20	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
Glyburide	GLYBURIDE	NuCare Pharmaceuticals,Inc.	901c50d5-31e7-b073-e053-2995a90abfeb	2024-06-19	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
GLYBURIDE	GLYBURIDE	A-S Medication Solutions	7a280f88-26d4-4fe5-a89b-a6f1d90ed3cd	2023-12-03	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
GLYBURIDE	GLYBURIDE	A-S Medication Solutions	3c91a408-973b-4572-832f-515f61d5be1f	2023-02-04	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
Glyburide	GLYBURIDE	Proficient Rx LP	b292cb9b-7348-4c07-a871-bc091229fdf8	2019-11-01	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
Glyburide	GLYBURIDE	Proficient Rx LP	240c3ac6-9aab-4185-994e-a0254e3aeb61	2019-11-01	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 89 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-1646	GLYBURIDE	GLYBURIDE	REMEDYREPACK INC.	ANDA	Current
70934-690	GLYBURIDE	GLYBURIDE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-855	GLYBURIDE	GLYBURIDE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0069	Glyburide	Glyburide	Bryant Ranch Prepack	ANDA	Current
71335-0069	GLYBURIDE	GLYBURIDE	Bryant Ranch Prepack	ANDA	Current
71335-0069	Glyburide	Glyburide	Bryant Ranch Prepack	ANDA	Current
71335-0150	Glyburide	Glyburide	Bryant Ranch Prepack	ANDA	Current
71335-0150	GLYBURIDE	GLYBURIDE	Bryant Ranch Prepack	ANDA	Current
71335-0150	Glyburide	Glyburide	Bryant Ranch Prepack	ANDA	Current