glyBURIDE

Product NDC: 52817-122
Requested package NDC: 52817-122-10
11-digit product format: 528170122
Labeler code: 52817
Product ID: 52817-122_b7928c2d-1e2e-a219-e053-2995a90aedee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: glyBURIDE
Dosage form: TABLET
Route: ORAL
Labeler: TruPharma, LLC
Application: ANDA203581
Marketing category: ANDA
Marketing start: 2016-06-01
Marketing end: 0000-00-00
Substance: GLYBURIDE
Active strength: 5 mg/1
Pharmacologic classes: Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52817-122	52817-122-10	D	Discontinued by firm		2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A203581-001	GLYBURIDE	GLYBURIDE	1.25MG	TABLET / ORAL	2016-04-14
A203581-002	GLYBURIDE	GLYBURIDE	2.5MG	TABLET / ORAL	2016-04-14
A203581-003	GLYBURIDE	GLYBURIDE	5MG	TABLET / ORAL	2016-04-14

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	A203581-001	GLYBURIDE	1.25MG	TABLET / ORAL	2016-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203581-002	GLYBURIDE	2.5MG	TABLET / ORAL	2016-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203581-003	GLYBURIDE	5MG	TABLET / ORAL	2016-04-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203581-001	GLYBURIDE	1.25MG	TABLET / ORAL	2016-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203581-002	GLYBURIDE	2.5MG	TABLET / ORAL	2016-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203581-003	GLYBURIDE	5MG	TABLET / ORAL	2016-04-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203581-001	GLYBURIDE	1.25MG	TABLET / ORAL	2016-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203581-002	GLYBURIDE	2.5MG	TABLET / ORAL	2016-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203581-003	GLYBURIDE	5MG	TABLET / ORAL	2016-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203581-001	GLYBURIDE	1.25MG	TABLET / ORAL	2016-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203581-002	GLYBURIDE	2.5MG	TABLET / ORAL	2016-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203581-003	GLYBURIDE	5MG	TABLET / ORAL	2016-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203581-001	GLYBURIDE	1.25MG	TABLET / ORAL	2016-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203581-002	GLYBURIDE	2.5MG	TABLET / ORAL	2016-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203581-003	GLYBURIDE	5MG	TABLET / ORAL	2016-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203581-001	GLYBURIDE	1.25MG	TABLET / ORAL	2016-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203581-002	GLYBURIDE	2.5MG	TABLET / ORAL	2016-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203581-003	GLYBURIDE	5MG	TABLET / ORAL	2016-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203581-001	GLYBURIDE	1.25MG	TABLET / ORAL	2016-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203581-002	GLYBURIDE	2.5MG	TABLET / ORAL	2016-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203581-003	GLYBURIDE	5MG	TABLET / ORAL	2016-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203581-001	GLYBURIDE	1.25MG	TABLET / ORAL	2016-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203581-002	GLYBURIDE	2.5MG	TABLET / ORAL	2016-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203581-003	GLYBURIDE	5MG	TABLET / ORAL	2016-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203581-001	GLYBURIDE	1.25MG	TABLET / ORAL	2016-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203581-002	GLYBURIDE	2.5MG	TABLET / ORAL	2016-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203581-003	GLYBURIDE	5MG	TABLET / ORAL	2016-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203581-001	GLYBURIDE	1.25MG	TABLET / ORAL	2016-04-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203581-002	GLYBURIDE	2.5MG	TABLET / ORAL	2016-04-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203581-003	GLYBURIDE	5MG	TABLET / ORAL	2016-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203581-001	GLYBURIDE	1.25MG	TABLET / ORAL	2016-04-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203581-002	GLYBURIDE	2.5MG	TABLET / ORAL	2016-04-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203581-003	GLYBURIDE	5MG	TABLET / ORAL	2016-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203581-001	GLYBURIDE	1.25MG	TABLET / ORAL	2016-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203581-002	GLYBURIDE	2.5MG	TABLET / ORAL	2016-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203581-003	GLYBURIDE	5MG	TABLET / ORAL	2016-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203581-001	GLYBURIDE	1.25MG	TABLET / ORAL	2016-04-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203581-002	GLYBURIDE	2.5MG	TABLET / ORAL	2016-04-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203581-003	GLYBURIDE	5MG	TABLET / ORAL	2016-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203581-001	GLYBURIDE	1.25MG	TABLET / ORAL	2016-04-14	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A203581-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203581-002	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203581-003	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203581-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203581-002	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203581-003	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203581-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203581-002	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203581-003	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203581-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203581-002	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203581-003	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203581-001	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203581-002	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203581-003	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203581-001	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203581-002	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203581-003	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203581-001	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203581-002	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203581-003	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203581-001	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203581-002	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203581-003	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203581-001	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203581-002	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203581-003	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203581-001	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203581-002	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203581-003	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203581-001	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203581-002	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203581-003	AB1	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52817-122-00	EA - Each	52817-122	c55b447a-daca-4e46-9800-a627bb6bcc49	1	2016-09-02
52817-122-10	EA - Each	52817-122	e59d8b86-80ce-4553-970d-886f131d7192	1	2016-09-02

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
310537	glyBURIDE 5 MG Oral Tablet	PSN	7f45c4ad-aa60-40d7-81f7-90c256f3df9f	2
310537	glyburide 5 MG Oral Tablet	SCD	7f45c4ad-aa60-40d7-81f7-90c256f3df9f	2
310537	glibenclamide 5 MG Oral Tablet	SY	7f45c4ad-aa60-40d7-81f7-90c256f3df9f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52817-122-10	52817012210	100 TABLET in 1 BOTTLE (52817-122-10)	100 tablet	2016-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
glyBURIDE	TruPharma, LLC \| Swiss Pharmaceutical Company Limited \| Apace Packaging, LLC \| Pharmadax (Foshan) Co.,Ltd	2020-12-28	HUMAN PRESCRIPTION DRUG LABEL	11
glyBURIDE - A-S Medication Solutions	A-S Medication Solutions	2019-06-11	HUMAN PRESCRIPTION DRUG LABEL	2