Application 020051

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLYNASE	GLYBURIDE	TABLET;ORAL	1.5MG	Yes	No
002	GLYNASE	GLYBURIDE	TABLET;ORAL	3MG	Yes	No
003	GLYNASE	GLYBURIDE	TABLET;ORAL	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	GLYNASE	GLYBURIDE	TABLET;ORAL	6MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020051-001	GLYNASE	GLYBURIDE	1.5MG	TABLET / ORAL	RLD	1992-03-04
N020051-002	GLYNASE	GLYBURIDE	3MG	TABLET / ORAL	RLD	1992-03-04
N020051-003	GLYNASE	GLYBURIDE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-09-24
N020051-004	GLYNASE	GLYBURIDE	6MG	TABLET / ORAL	RLD	1993-09-24

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 5 · 168 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
2026-08-18 06:07:40	2026-07	N020051-001	GLYNASE	1.5MG	TABLET / ORAL		RLD	1992-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020051-002	GLYNASE	3MG	TABLET / ORAL		RLD	1992-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020051-003	GLYNASE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020051-004	GLYNASE	6MG	TABLET / ORAL		RLD	1993-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020051-001	GLYNASE	1.5MG	TABLET / ORAL		RLD	1992-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020051-002	GLYNASE	3MG	TABLET / ORAL		RLD	1992-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020051-003	GLYNASE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020051-004	GLYNASE	6MG	TABLET / ORAL		RLD	1993-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020051-001	GLYNASE	1.5MG	TABLET / ORAL		RLD	1992-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020051-002	GLYNASE	3MG	TABLET / ORAL		RLD	1992-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020051-003	GLYNASE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020051-004	GLYNASE	6MG	TABLET / ORAL		RLD	1993-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020051-001	GLYNASE	1.5MG	TABLET / ORAL	AB	RLD	1992-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020051-002	GLYNASE	3MG	TABLET / ORAL	AB	RLD	1992-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020051-003	GLYNASE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020051-004	GLYNASE	6MG	TABLET / ORAL	AB	RLD, RS	1993-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020051-001	GLYNASE	1.5MG	TABLET / ORAL	AB	RLD	1992-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020051-002	GLYNASE	3MG	TABLET / ORAL	AB	RLD	1992-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020051-003	GLYNASE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020051-004	GLYNASE	6MG	TABLET / ORAL	AB	RLD, RS	1993-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020051-001	GLYNASE	1.5MG	TABLET / ORAL	AB	RLD	1992-03-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020051-002	GLYNASE	3MG	TABLET / ORAL	AB	RLD	1992-03-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020051-003	GLYNASE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020051-004	GLYNASE	6MG	TABLET / ORAL	AB	RLD, RS	1993-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020051-001	GLYNASE	1.5MG	TABLET / ORAL	AB	RLD	1992-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020051-002	GLYNASE	3MG	TABLET / ORAL	AB	RLD	1992-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020051-003	GLYNASE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020051-004	GLYNASE	6MG	TABLET / ORAL	AB	RLD, RS	1993-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020051-001	GLYNASE	1.5MG	TABLET / ORAL	AB	RLD	1992-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020051-002	GLYNASE	3MG	TABLET / ORAL	AB	RLD	1992-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020051-003	GLYNASE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020051-004	GLYNASE	6MG	TABLET / ORAL	AB	RLD, RS	1993-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020051-001	GLYNASE	1.5MG	TABLET / ORAL	AB	RLD	1992-03-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020051-002	GLYNASE	3MG	TABLET / ORAL	AB	RLD	1992-03-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020051-003	GLYNASE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020051-004	GLYNASE	6MG	TABLET / ORAL	AB	RLD, RS	1993-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020051-001	GLYNASE	1.5MG	TABLET / ORAL	AB	RLD	1992-03-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020051-002	GLYNASE	3MG	TABLET / ORAL	AB	RLD	1992-03-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020051-003	GLYNASE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020051-004	GLYNASE	6MG	TABLET / ORAL	AB	RLD, RS	1993-09-24	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N020051-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020051-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020051-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020051-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020051-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020051-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020051-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020051-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020051-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020051-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020051-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020051-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020051-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020051-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020051-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020051-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020051-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020051-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020051-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020051-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020051-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020051-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020051-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020051-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020051-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020051-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020051-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020051-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020051-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020051-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020051-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020051-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020051-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020051-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020051-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020051-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020051-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020051-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020051-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020051-001	AB	1	`5d02ea3f76ae…`

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 2 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glyburide	GLYBURIDE	REMEDYREPACK INC.	524eec41-37ee-419a-b7a1-d23e888ae6ab	2026-06-12	Warnings, Adverse reactions	Name fallback generic name: GLYBURIDE
GLYBURIDE	GLYBURIDE	Bryant Ranch Prepack	9cdd30e7-512a-4f00-a4de-0a154d143ce9	2026-05-18	Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	REMEDYREPACK INC.	e23b9a3b-0184-4d1c-8e2c-668697a6da87	2026-05-15	Warnings, Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	Preferred Pharmaceuticals Inc.	cf21c8c0-7247-4d5b-97f8-ae4016144642	2026-05-07	Warnings, Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	Preferred Pharmaceuticals Inc.	bc8df889-25e0-49a0-bbec-a3dfae8bbb8a	2026-01-27	Warnings, Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	A-S Medication Solutions	51cf08e2-8a2f-4bde-996f-f431f1a68abd	2026-01-20	Warnings, Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	NuCare Pharmaceuticals,Inc.	ffd31d06-6011-34e2-e053-6394a90a437f	2026-01-16	Warnings, Adverse reactions	Name fallback generic name: GLYBURIDE
GLYBURIDE	GLYBURIDE	Northwind Health Company, LLC	d9cb9251-7b31-72a0-e053-2a95a90a4315	2026-01-01	Adverse reactions	Name fallback generic name: GLYBURIDE
GLYBURIDE	GLYBURIDE	Northwind Health Company, LLC	db47a517-f8bb-136f-e053-2a95a90ad8c5	2026-01-01	Adverse reactions	Name fallback generic name: GLYBURIDE
GLYBURIDE	GLYBURIDE	Chartwell RX, LLC	7e661288-2d24-4403-86a1-754afa1d04ff	2025-12-09	Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	Coupler LLC	4573af7f-3c71-e323-e063-6394a90aa9eb	2025-12-08	Warnings, Adverse reactions	Name fallback generic name: GLYBURIDE
GLYBURIDE	GLYBURIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	33418bba-c5ea-4c0f-9d28-31dc2724c6c3	2025-10-31	Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	Bryant Ranch Prepack	db074991-1267-454a-8b1d-b6f52e2132cc	2025-10-03	Warnings, Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	Proficient Rx LP	6f65131c-90df-45ab-95fb-c36f411c6fbe	2025-07-01	Warnings, Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	NuCare Pharmaceuticals,Inc.	7ee41cd3-461f-3408-e053-2991aa0a863d	2025-02-06	Adverse reactions	Name fallback generic name: GLYBURIDE
GLYBURIDE	GLYBURIDE	Bryant Ranch Prepack	05341afe-5b7a-462a-a196-689cb09f83fc	2025-01-28	Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	A-S Medication Solutions	676c0e45-0aa2-4060-ad18-67abb9873a50	2024-10-28	Warnings, Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	NuCare Pharmaceuticals, Inc.	25516c2a-f1b5-9ee4-e063-6394a90ab46b	2024-10-25	Warnings, Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	NuCare Pharmaceuticals, Inc.	21786ac0-da3c-16cb-e063-6394a90a4596	2024-09-06	Warnings, Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	NuCare Pharmaceuticals, Inc.	3e354b4d-70e4-5089-e054-00144ff88e88	2024-08-13	Adverse reactions	Name fallback generic name: GLYBURIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-0341	Glynase	glyburide	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0352	Glynase	glyburide	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3449	Glynase	glyburide	Pharmacia and Upjohn Company LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49581	SUPPL	2017-08-29
49524	SUPPL	2017-08-24
34214	SUPPL	2015-05-27
1955	SUPPL	2015-05-26
34213	SUPPL	2013-10-22
21081	SUPPL	2013-10-16
1954	SUPPL	2011-02-09
34212	SUPPL	2011-02-07
1953	SUPPL	2009-11-19
34211	SUPPL	2009-09-17
34210	SUPPL	2008-11-07
1952	SUPPL	2008-11-03
20462	SUPPL	1997-01-10