GLYBURIDE

Manufacturer: DirectRX
Effective date: 2015-12-04
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:21:37

Label at a glance#

ProductGLYBURIDE

Active ingredientGLYBURIDE

Label structure1 sections

Label contents#

Full prescribing information#

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310537	glyBURIDE 5 MG Oral Tablet	PSN	1
310537	glyburide 5 MG Oral Tablet	SCD	1
310537	glibenclamide 5 MG Oral Tablet	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
GLYBURIDE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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
61919-378-60	2020-01-31	C162847	48780-1	9d75b9cf-d061-f424-e053-dadaa90a57ce	GLYBURIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-378-60	GLYBURIDE	60 in 1 BOTTLE	TABLET	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-378	GLYBURIDE TABLET [DIRECTRX]	1	Legacy NDC, 1 package rows	20151204_2615ee96-7a3d-5cde-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-378-60	EA - Each	61919-378	afb137c6-4ac2-4fb6-b341-d7647c2d3dc9	1	2016-02-04
61919-378-90	EA - Each	61919-378	a11b2d1d-4f63-4f4c-a13b-23014702c5a6	1	2019-08-06
23155-058-01	EA - Each	23155-058	3f130585-9a51-46d9-af15-3e46cf048254	1	2012-07-24
23155-058-10	EA - Each	23155-058	b47a6afe-ec6b-4b77-885e-9f3c551fbc31	1	2012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

GLYBURIDE
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61919-378	61919-378-60
23155-058

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYBURIDE	SX6K58TVWC	ACTIB
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
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 · 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	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090937-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2011-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090937-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2011-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090937-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2011-02-28	`caaa826d4ba7…`
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…`

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	A090937-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090937-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090937-003	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090937-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090937-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090937-003	AB1	1	`caaa826d4ba7…`
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…`

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	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	33418bba-c5ea-4c0f-9d28-31dc2724c6c3	2025-10-31	Adverse reactions	Exact identifier ndc (product): 23155-058
2615ee96-7a3e-5cde-e054-00144ff8d46c			2615ee96-7a3d-5cde-e054-00144ff8d46c	2015-12-04	Adverse reactions	Exact identifier spl id: 2615ee96-7a3e-5cde-e054-00144ff8d46c spl set id: 2615ee96-7a3d-5cde-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.