Application 206749

Type: ANDA
Sponsor: ZYDUS PHARMS

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
A206749-001	GLYBURIDE	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2016-05-10
A206749-002	GLYBURIDE	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2016-05-10
A206749-003	GLYBURIDE	GLYBURIDE	5MG	TABLET / ORAL	AB1	2016-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206749-001	AB1
A206749-002	AB1
A206749-003	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	A206749-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2016-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206749-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2016-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206749-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2016-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206749-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2016-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206749-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2016-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206749-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2016-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206749-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2016-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206749-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2016-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206749-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2016-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206749-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2016-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206749-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2016-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206749-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2016-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206749-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2016-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206749-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2016-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206749-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2016-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206749-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2016-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206749-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2016-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206749-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2016-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206749-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2016-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206749-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2016-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206749-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2016-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206749-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2016-05-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206749-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2016-05-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206749-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2016-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206749-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2016-05-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206749-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2016-05-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206749-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2016-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206749-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2016-05-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206749-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2016-05-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206749-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2016-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206749-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2016-05-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206749-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2016-05-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206749-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2016-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206749-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2016-05-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206749-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2016-05-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206749-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2016-05-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206749-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2016-05-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206749-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2016-05-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206749-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2016-05-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206749-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2016-05-10	`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	A206749-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206749-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206749-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206749-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206749-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206749-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206749-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206749-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206749-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206749-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206749-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206749-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206749-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206749-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206749-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206749-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206749-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206749-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206749-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206749-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206749-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206749-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206749-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206749-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206749-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206749-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206749-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206749-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206749-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206749-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206749-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206749-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206749-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206749-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206749-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206749-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206749-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206749-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206749-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206749-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
glyburide	GLYBURIDE	Zydus Lifesciences Limited	5d0e406f-285d-4716-8971-82f665345517	2022-11-16	Adverse reactions	Exact identifier application applno (ANDA): 206749 application number: ANDA206749 ndc (product): 65841-832 ndc (product): 65841-833 ndc (product): 65841-834
glyburide	GLYBURIDE	Zydus Pharmaceuticals (USA) Inc.	87781ea8-62ec-483c-a4dd-8c965ce59485	2022-11-16	Adverse reactions	Exact identifier application applno (ANDA): 206749 application number: ANDA206749 ndc (product): 68382-656 ndc (product): 68382-657 ndc (product): 68382-658

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3012	glyburide	glyburide	A-S Medication Solutions	ANDA	Current
65841-832	glyburide	glyburide	Zydus Lifesciences Limited	ANDA	Current
65841-832	glyburide	glyburide	Cadila Healthcare Limited	ANDA	Current
65841-832	glyburide	glyburide	Cadila Healthcare Limited	ANDA	Current
65841-833	glyburide	glyburide	Zydus Lifesciences Limited	ANDA	Current
65841-833	glyburide	glyburide	Cadila Healthcare Limited	ANDA	Current
65841-833	glyburide	glyburide	Cadila Healthcare Limited	ANDA	Current
65841-834	glyburide	glyburide	Zydus Lifesciences Limited	ANDA	Current
65841-834	glyburide	glyburide	Cadila Healthcare Limited	ANDA	Current
65841-834	glyburide	glyburide	Cadila Healthcare Limited	ANDA	Current
68382-656	glyburide	glyburide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-656	glyburide	glyburide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-656	glyburide	glyburide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-657	glyburide	glyburide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-657	glyburide	glyburide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-657	glyburide	glyburide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-658	glyburide	glyburide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-658	glyburide	glyburide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-658	glyburide	glyburide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current