Application 074388

Type: ANDA
Sponsor: TEVA

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	Yes

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	RLD / RS	Approval date
A074388-001	GLYBURIDE	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29
A074388-002	GLYBURIDE	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29
A074388-003	GLYBURIDE	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074388-001	AB1
A074388-002	AB1
A074388-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`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	A074388-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074388-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074388-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074388-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074388-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074388-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074388-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074388-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074388-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074388-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074388-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074388-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074388-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074388-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074388-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074388-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074388-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074388-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074388-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074388-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074388-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074388-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074388-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074388-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074388-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074388-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074388-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074388-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074388-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074388-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074388-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074388-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074388-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074388-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074388-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074388-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074388-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074388-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074388-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074388-001	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glyburide	GLYBURIDE	Preferred Pharmaceuticals Inc.	bc8df889-25e0-49a0-bbec-a3dfae8bbb8a	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074388 application number: ANDA074388
Glyburide	GLYBURIDE	Coupler LLC	4573af7f-3c71-e323-e063-6394a90aa9eb	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074388 application number: ANDA074388
Glyburide	GLYBURIDE	Proficient Rx LP	6f65131c-90df-45ab-95fb-c36f411c6fbe	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074388 application number: ANDA074388
Glyburide	GLYBURIDE	NuCare Pharmaceuticals, Inc.	25516c2a-f1b5-9ee4-e063-6394a90ab46b	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074388 application number: ANDA074388
Glyburide	GLYBURIDE	NuCare Pharmaceuticals, Inc.	21786ac0-da3c-16cb-e063-6394a90a4596	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074388 application number: ANDA074388
Glyburide	GLYBURIDE	A-S Medication Solutions	922d1080-52c6-41e4-a310-533d8ca18594	2023-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074388 application number: ANDA074388
Glyburide	GLYBURIDE	Proficient Rx LP	ec45f0d8-cab8-4822-895b-17bb443a4f98	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074388 application number: ANDA074388 ndc (product): 63187-848
Glyburide	GLYBURIDE	Teva Pharmaceuticals USA, Inc.	a56f100f-0f42-4188-81ab-04644b824040	2015-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074388 application number: ANDA074388 ndc (product): 0093-8344 ndc (product): 0093-8342 ndc (product): 0093-8343

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-8342	Glyburide	Glyburide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8342	Glyburide	Glyburide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8342	Glyburide	Glyburide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8343	Glyburide	Glyburide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8343	Glyburide	Glyburide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8343	Glyburide	Glyburide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8344	Glyburide	Glyburide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8344	Glyburide	Glyburide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8344	Glyburide	Glyburide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0615-1556	Glyburide	Glyburide	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-4509	Glyburide	Glyburide	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
42291-316	Glyburide	Glyburide	AvKARE, Inc.	ANDA	Current
42291-316	Glyburide	Glyburide	AvKARE	ANDA	Current
42291-317	Glyburide	Glyburide	AvKARE, Inc.	ANDA	Current
42291-317	Glyburide	Glyburide	AvKARE	ANDA	Current
49999-113	Glyburide	Glyburide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-0494	Glyburide	Glyburide	A-S Medication Solutions	ANDA	Current
50090-3429	Glyburide	Glyburide	A-S Medication Solutions	ANDA	Current
50090-3429	Glyburide	Glyburide	A-S Medication Solutions	ANDA	Current
50090-3429	Glyburide	Glyburide	A-S Medication Solutions	ANDA	Current
50436-6409	Glyburide	Glyburide	Unit Dose Services	ANDA	Current
51079-872	Glyburide	Glyburide	Mylan Institutional Inc.	ANDA	Current
51079-872	Glyburide	Glyburide	Mylan Institutional Inc.	ANDA	Current
51079-873	Glyburide	Glyburide	Mylan Institutional Inc.	ANDA	Current
51079-873	Glyburide	Glyburide	Mylan Institutional Inc.	ANDA	Current
63187-848	Glyburide	Glyburide	Proficient Rx LP	ANDA	Current
63187-848	Glyburide	Glyburide	Proficient Rx LP	ANDA	Current
63629-1393	Glyburide	Glyburide	Bryant Ranch Prepack	ANDA	Current
63629-1393	Glyburide	Glyburide	Bryant Ranch Prepack	ANDA	Current
63629-2907	Glyburide	Glyburide	Bryant Ranch Prepack	ANDA	Current
63629-2907	Glyburide	Glyburide	Bryant Ranch Prepack	ANDA	Current
63739-119	Glyburide	Glyburide	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-119	Glyburide	Glyburide	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-119	Glyburide	Glyburide	McKesson Corporation	ANDA	Current
66116-360	Glyburide	Glyburide	MedVantx, Inc.	ANDA	Current
68071-2189	Glyburide	Glyburide	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-6885	Glyburide	Glyburide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6885	Glyburide	Glyburide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6885	Glyburide	Glyburide	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0019	Glyburide	Glyburide	REMEDYREPACK INC.	ANDA	Current
70934-715	Glyburide	Glyburide	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current