GLYBURIDE

Product NDC: 68071-5217
11-digit product format: 680715217
Labeler code: 68071
Product ID: 68071-5217_1b58e185-0bf6-c0eb-e063-6294a90a4d9f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GLYBURIDE
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA090937
Marketing category: ANDA
Marketing start: 2010-10-05
Substance: GLYBURIDE
Active strength: 2.5 mg/1
Pharmacologic classes: Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: 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	Approval date
A090937-001	GLYBURIDE	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28
A090937-002	GLYBURIDE	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28
A090937-003	GLYBURIDE	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090937-001	AB1
A090937-002	AB1
A090937-003	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	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`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	A090937-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090937-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090937-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090937-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090937-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090937-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090937-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090937-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090937-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090937-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090937-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090937-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090937-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090937-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090937-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090937-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090937-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090937-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090937-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090937-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090937-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090937-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090937-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090937-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090937-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090937-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090937-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090937-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090937-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090937-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090937-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090937-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090937-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090937-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090937-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090937-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090937-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090937-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090937-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090937-001	AB1	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: GLYBURIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLYBURIDE	2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SX6K58TVWC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310534	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a1233548-bbb8-34aa-e053-2a95a90aea53	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bea938a6-c880-985b-d27b-b59b0d8b5a77	Product name	3	20170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2f	Product name	1	20170616
64b2b6e2-1c04-cf4a-db4c-078ed10e1dd6	Product name	2	20160609
5a2baaae-1290-c05e-207f-b1367e9eb46a	Product name	2	20151005
b044018d-bcdc-e68d-63da-1ad6886aea64	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-5217-0	2022-02-07	C162847	48780-1	d6a99b39-d523-a426-e053-dadaa90af4c2	Glyburide Tablets, USP Rx only
68071-5217-0	2022-01-28	C162847	48780-1	d6a99b39-d523-a426-e053-dadaa90af4c2	Glyburide Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-5217-0	GLYBURIDE	100 in 1 BOTTLE	TABLET	100		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-5217	GLYBURIDE TABLET [NUCARE PHARMACEUTICALS,INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240622_a1233548-bbb8-34aa-e053-2a95a90aea53.zip

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GLYBURIDE	GLYBURIDE	Bryant Ranch Prepack	9cdd30e7-512a-4f00-a4de-0a154d143ce9	2026-05-18	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
GLYBURIDE	GLYBURIDE	Northwind Health Company, LLC	d9cb9251-7b31-72a0-e053-2a95a90a4315	2026-01-01	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
GLYBURIDE	GLYBURIDE	Northwind Health Company, LLC	db47a517-f8bb-136f-e053-2a95a90ad8c5	2026-01-01	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
GLYBURIDE	GLYBURIDE	Chartwell RX, LLC	7e661288-2d24-4403-86a1-754afa1d04ff	2025-12-09	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
GLYBURIDE	GLYBURIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	33418bba-c5ea-4c0f-9d28-31dc2724c6c3	2025-10-31	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
Glyburide	GLYBURIDE	NuCare Pharmaceuticals,Inc.	7ee41cd3-461f-3408-e053-2991aa0a863d	2025-02-06	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
GLYBURIDE	GLYBURIDE	Bryant Ranch Prepack	05341afe-5b7a-462a-a196-689cb09f83fc	2025-01-28	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
Glyburide	GLYBURIDE	NuCare Pharmaceuticals, Inc.	3e354b4d-70e4-5089-e054-00144ff88e88	2024-08-13	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
GLYBURIDE	GLYBURIDE	NuCare Pharmaceuticals,Inc.	a12342fb-123c-2951-e053-2a95a90ac596	2024-06-20	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
GLYBURIDE	GLYBURIDE	NuCare Pharmaceuticals,Inc.	a1233548-bbb8-34aa-e053-2a95a90aea53	2024-06-20	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937 ndc (product): 68071-5217
Glyburide	GLYBURIDE	NuCare Pharmaceuticals,Inc.	901c50d5-31e7-b073-e053-2995a90abfeb	2024-06-19	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
GLYBURIDE	GLYBURIDE	A-S Medication Solutions	7a280f88-26d4-4fe5-a89b-a6f1d90ed3cd	2023-12-03	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
GLYBURIDE	GLYBURIDE	A-S Medication Solutions	3c91a408-973b-4572-832f-515f61d5be1f	2023-02-04	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
Glyburide	GLYBURIDE	Proficient Rx LP	b292cb9b-7348-4c07-a871-bc091229fdf8	2019-11-01	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937
Glyburide	GLYBURIDE	Proficient Rx LP	240c3ac6-9aab-4185-994e-a0254e3aeb61	2019-11-01	Adverse reactions	Exact identifier application applno (ANDA): 090937 application number: ANDA090937

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SX6K58TVWC	GLYBURIDE	10238-21-8	GLYBURIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310534	glyBURIDE 2.5 MG Oral Tablet	PSN	a1233548-bbb8-34aa-e053-2a95a90aea53	3
310534	glyburide 2.5 MG Oral Tablet	SCD	a1233548-bbb8-34aa-e053-2a95a90aea53	3
310534	glibenclamide 2.5 MG Oral Tablet	SY	a1233548-bbb8-34aa-e053-2a95a90aea53	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-5217-0	68071521700	100 TABLET in 1 BOTTLE (68071-5217-0)	100 tablet	2020-03-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glyburide Tablets, USP Rx only	NuCare Pharmaceuticals,Inc.	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL	3