Glyburide

Product NDC: 59115-014
11-digit product format: 591150014
Labeler code: 59115
Product ID: 59115-014_f2e6f347-50f7-4f73-bb81-6ca39e66093c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glyburide
Dosage form: TABLET
Route: ORAL
Labeler: Hikma Pharmaceutical
Application: ANDA075890
Marketing category: ANDA
Marketing start: 2003-08-01
Marketing end: 0000-00-00
Substance: GLYBURIDE
Active strength: 2 mg/1
Pharmacologic classes: Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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	Approval date
A075890-001	GLYBURIDE (MICRONIZED)	GLYBURIDE	1.5MG	TABLET / ORAL	2003-07-31
A075890-002	GLYBURIDE (MICRONIZED)	GLYBURIDE	3MG	TABLET / ORAL	2003-07-31
A075890-003	GLYBURIDE (MICRONIZED)	GLYBURIDE	6MG	TABLET / ORAL	2003-07-31

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075890-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	2003-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075890-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	2003-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075890-003	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	2003-07-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075890-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	2003-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075890-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	2003-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075890-003	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	2003-07-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075890-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	2003-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075890-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	2003-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075890-003	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	2003-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075890-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	2003-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075890-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	2003-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075890-003	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	2003-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075890-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	2003-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075890-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	2003-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075890-003	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	2003-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075890-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	2003-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075890-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	2003-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075890-003	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	2003-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075890-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	2003-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075890-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	2003-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075890-003	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	2003-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075890-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	2003-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075890-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	2003-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075890-003	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	2003-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075890-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	2003-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075890-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	2003-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075890-003	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	2003-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075890-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	2003-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075890-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	2003-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075890-003	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	2003-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075890-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	2003-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075890-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	2003-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075890-003	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	2003-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075890-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	2003-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075890-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	2003-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075890-003	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	2003-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075890-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	2003-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075890-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	2003-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075890-003	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	2003-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075890-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	2003-07-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 69 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075890-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075890-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075890-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075890-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075890-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075890-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075890-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075890-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075890-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075890-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075890-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075890-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A075890-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A075890-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075890-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A075890-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A075890-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075890-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075890-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075890-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075890-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075890-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075890-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075890-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A075890-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A075890-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075890-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075890-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075890-003	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLYBURIDE	ACTIVE INGREDIENT	SX6K58TVWC	GLYBURIDE TABLET [HIKMA PHARMACEUTICAL]	4
GLYBURIDE	ACTIVE MOIETY	SX6K58TVWC	GLYBURIDE TABLET [HIKMA PHARMACEUTICAL]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GLYBURIDE TABLET [HIKMA PHARMACEUTICAL]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GLYBURIDE TABLET [HIKMA PHARMACEUTICAL]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLYBURIDE TABLET [HIKMA PHARMACEUTICAL]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLYBURIDE TABLET [HIKMA PHARMACEUTICAL]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GLYBURIDE TABLET [HIKMA PHARMACEUTICAL]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GLYBURIDE TABLET [HIKMA PHARMACEUTICAL]	4

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GLYBURIDE TABLETS, USP (Micronized) Rev. 06/13 Rx Only For Oral Use	Hikma Pharmaceutical	2015-02-11	HUMAN PRESCRIPTION DRUG LABEL	5

Glyburide

Orange Book products#

Observed Orange Book product history#

Observed Orange Book normalized TE history#

Reported adverse events (FAERS/openFDA)#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#