Application 079009

Type: ANDA
Sponsor: HERITAGE PHARMS INC

Application Products#

Product, Drug, Ingredient table
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

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
A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03
A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03
A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079009-001	AB
A079009-002	AB
A079009-003	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.

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	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 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	A079009-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079009-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079009-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079009-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079009-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079009-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079009-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079009-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079009-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079009-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079009-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079009-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079009-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079009-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079009-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079009-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079009-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079009-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079009-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079009-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079009-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079009-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079009-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079009-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079009-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079009-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079009-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079009-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079009-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079009-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079009-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079009-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079009-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079009-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079009-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079009-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079009-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079009-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079009-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079009-001	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.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
glyburide-metformin hydrochloride	GLYBURIDE-METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	b5ccf5da-cbe1-4009-ba1c-990050838ee9	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079009 application number: ANDA079009
glyburide-metformin hydrochloride	GLYBURIDE-METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	a086cc29-cb5d-40d0-a57d-8e91f1aa9158	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079009 application number: ANDA079009
glyburide-metformin hydrochloride	GLYBURIDE-METFORMIN HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b38213bb-d663-4c95-a1b2-96c23ee5be09	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079009 application number: ANDA079009 ndc (product): 23155-234 ndc (product): 23155-233 ndc (product): 23155-235
glyburide-metformin hydrochloride	GLYBURIDE-METFORMIN HYDROCHLORIDE	A-S Medication Solutions	f43c087a-7135-4a79-8463-fe5e9319da91	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079009 application number: ANDA079009
glyburide-metformin hydrochloride	GLYBURIDE-METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a0ff8ee6-0da8-40f8-b5b0-a7b334e1a15f	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079009 application number: ANDA079009
glyburide-metformin hydrochloride	GLYBURIDE-METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	486fec17-ff83-3bab-e063-6394a90a5ef0	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079009 application number: ANDA079009
glyburide-metformin hydrochloride	GLYBURIDE-METFORMIN HYDROCHLORIDE	A-S Medication Solutions	faa19e1b-2782-4bf1-a93f-84755f7aa53f	2025-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079009 application number: ANDA079009

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-579	Glyburide-Metformin Hydrochloride	Glyburide-Metformin Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
10544-580	Glyburide-Metformin Hydrochloride	Glyburide-Metformin Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
23155-233	glyburide-metformin hydrochloride	glyburide-metformin hydrochloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-233	Glyburide-Metformin Hydrochloride	Glyburide-Metformin Hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-234	glyburide-metformin hydrochloride	glyburide-metformin hydrochloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-234	Glyburide-Metformin Hydrochloride	Glyburide-Metformin Hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-235	glyburide-metformin hydrochloride	glyburide-metformin hydrochloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-235	Glyburide-Metformin Hydrochloride	Glyburide-Metformin Hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
55111-695	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE AND METFORMIN HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-696	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE AND METFORMIN HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-697	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE AND METFORMIN HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	ANDA	Current