Glyburide and Metformin

Product NDC: 42254-071
11-digit product format: 422540071
Labeler code: 42254
Product ID: 42254-071_8ca95053-18cb-468d-8e72-e02cf4d7c3bc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glyburide and Metformin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA076345
Marketing category: ANDA
Marketing start: 2011-01-02
Marketing end: 0000-00-00
Substance: GLYBURIDE; METFORMIN HYDROCHLORIDE
Active strength: 3 mg/1; mg/1
Pharmacologic classes: Sulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42254-071		I	Inactivated by FDA		2026-10-05
excluded package	package	42254-071	42254-071-30	I	Inactivated by FDA		2026-10-05

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42254-071-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42254-071-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42254-071-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42254-071-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42254-071-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42254-071-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42254-071-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42254-071-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42254-071-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42254-071-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42254-071-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42254-071-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42254-071-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42254-071-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42254-071-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42254-071-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42254-071-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42254-071-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42254-071-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42254-071-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42254-071-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42254-071-30	`110d247fa046…`	`a55b01930146…`

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
A076345-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2004-02-18
A076345-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2004-02-18
A076345-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2004-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076345-001	AB
A076345-002	AB
A076345-003	AB

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	A076345-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2004-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076345-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2004-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076345-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2004-02-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076345-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2004-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076345-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2004-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076345-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2004-02-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076345-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2004-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076345-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2004-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076345-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2004-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076345-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2004-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076345-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2004-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076345-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2004-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076345-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2004-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076345-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2004-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076345-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2004-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076345-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2004-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076345-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2004-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076345-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2004-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076345-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2004-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076345-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2004-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076345-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2004-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076345-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2004-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076345-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2004-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076345-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2004-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076345-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2004-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076345-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2004-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076345-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2004-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076345-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2004-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076345-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2004-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076345-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2004-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076345-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2004-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076345-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2004-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076345-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2004-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076345-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2004-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076345-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2004-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076345-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2004-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076345-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2004-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076345-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2004-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076345-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2004-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076345-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2004-02-18	`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	A076345-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076345-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076345-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076345-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076345-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076345-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076345-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076345-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076345-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076345-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076345-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076345-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076345-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076345-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076345-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076345-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076345-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076345-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076345-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076345-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076345-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076345-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076345-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076345-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076345-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076345-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076345-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076345-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076345-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076345-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076345-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076345-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076345-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076345-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076345-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076345-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076345-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076345-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076345-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076345-001	AB	1	`301d65b070ca…`

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
6a29d87d-f465-752d-5fa9-bd728c608ca2	Product name	4	20251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698e	Product name	1	20250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5	Product name	7	20250515
25bfaa4d-02a1-402c-96ec-9bf6e625484c	Product name	1	20250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0	Product name	2	20240829
16dbe107-66d5-47b3-57ed-0cba6a8dfccc	Product name	6	20240215
08b3e508-8c7e-3b95-0275-113510642fc6	Product name	2	20220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8	Product name	1	20200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86	Product name	1	20200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5	Product name	1	20190731
ca3f036c-6c06-b829-b379-1a3a4097099c	Product name	9	20180605
e1ede89f-54c8-428f-ae84-9e8a2deb67db	Product name	1	20180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52c	Product name	2	20170824
bea938a6-c880-985b-d27b-b59b0d8b5a77	Product name	3	20170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2f	Product name	1	20170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cb	Product name	1	20170224
988f737f-e7e9-4613-8558-824b1ab755f9	Product name	1	20161128
58b66776-50d5-434f-916f-958ccf131e0e	Product name	1	20160713
64b2b6e2-1c04-cf4a-db4c-078ed10e1dd6	Product name	2	20160609
3e9b6ece-066b-2ac3-28f7-5e13060e5934	Product name	2	20151109
5a2baaae-1290-c05e-207f-b1367e9eb46a	Product name	2	20151005
2988466d-5fc4-4430-9cee-fc9132f02d2c	Product name	1	20150910
85cbb42f-1a8d-f945-f85e-188e823b7f5b	Product name	2	20150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7	Product name	1	20150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0	Product name	1	20141205
0d79b284-47e8-e90c-f249-892b9b251003	Product name	1	20140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6	Product name	1	20140508
2de6e143-c970-2061-1b77-61c3aa8f4026	Product name	1	20140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508
b044018d-bcdc-e68d-63da-1ad6886aea64	Product name	1	20140508
ce63c1f8-ba50-8a17-9290-94522d75daff	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42254-071-30	2019-09-24	C162847	48780-1	9350213a-3c08-c013-e053-90daa90a1393	GLYBURIDE and METFORMIN HYDROCHLORIDE TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42254-071-30	Glyburide and Metformin	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-071-30	EA - Each	42254-071	354b051a-d9ba-4046-9601-23ab3bf6afcd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Glyburide	ACTIVE INGREDIENT	SX6K58TVWC	GLYBURIDE AND METFORMIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
Metformin Hydrochloride	ACTIVE INGREDIENT	786Z46389E	GLYBURIDE AND METFORMIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
Glyburide	ACTIVE MOIETY	SX6K58TVWC	GLYBURIDE AND METFORMIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
METFORMIN	ACTIVE MOIETY	9100L32L2N	GLYBURIDE AND METFORMIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLYBURIDE AND METFORMIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	GLYBURIDE AND METFORMIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	GLYBURIDE AND METFORMIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	GLYBURIDE AND METFORMIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	GLYBURIDE AND METFORMIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GLYBURIDE AND METFORMIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLYBURIDE AND METFORMIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	GLYBURIDE AND METFORMIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GLYBURIDE AND METFORMIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GLYBURIDE AND METFORMIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GLYBURIDE AND METFORMIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-071	GLYBURIDE AND METFORMIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20120316_8ca95053-18cb-468d-8e72-e02cf4d7c3bc.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SX6K58TVWC	GLYBURIDE	10238-21-8	GLYBURIDE
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861748	glyBURIDE 2.5 MG / metFORMIN HCl 500 MG Oral Tablet	PSN	8ca95053-18cb-468d-8e72-e02cf4d7c3bc	1
861748	glyburide 2.5 MG / metformin hydrochloride 500 MG Oral Tablet	SCD	8ca95053-18cb-468d-8e72-e02cf4d7c3bc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42254-071-30	42254007130	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GLYBURIDE and METFORMIN HYDROCHLORIDE TABLETS USP Rx only	Rebel Distributors Corp	2011-12-20	HUMAN PRESCRIPTION DRUG LABEL	1