Application 206748

Type: ANDA
Sponsor: ZYDUS PHARMS

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 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
A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29
A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29
A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206748-001	AB
A206748-002	AB
A206748-003	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 · 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	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`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	A206748-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206748-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206748-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206748-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206748-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206748-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206748-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206748-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206748-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206748-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206748-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206748-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206748-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206748-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206748-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206748-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206748-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206748-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206748-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206748-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206748-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206748-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206748-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206748-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206748-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206748-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206748-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206748-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206748-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206748-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206748-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206748-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206748-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206748-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206748-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206748-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206748-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206748-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206748-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206748-001	AB	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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
glyburide and metformin hydrochloride	GLYBURIDE AND METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	2239742b-74e1-4bc2-b5a8-15c4758d6f7b	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206748 application number: ANDA206748 ndc (product): 68382-653 ndc (product): 68382-655 ndc (product): 68382-654
glyburide and metformin hydrochloride	GLYBURIDE AND METFORMIN HYDROCHLORIDE	Zydus Lifesciences Limited	df752bd4-e197-40a4-a01b-d48ba2c10516	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206748 application number: ANDA206748 ndc (product): 65841-824 ndc (product): 65841-825 ndc (product): 65841-826

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55700-469	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
65841-824	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Zydus Lifesciences Limited	ANDA	Current
65841-824	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-824	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-825	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Zydus Lifesciences Limited	ANDA	Current
65841-825	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-825	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-826	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Zydus Lifesciences Limited	ANDA	Current
65841-826	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-826	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Cadila Healthcare Limited	ANDA	Current
68382-653	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-653	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-653	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-653	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-654	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-654	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-654	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-654	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-655	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-655	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-655	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-655	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68788-6915	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6915	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6915	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-0114	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0114	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0114	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0127	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0127	glyburide and metformin hydrochloride	glyburide and metformin hydrochloride	Bryant Ranch Prepack	ANDA	Current