Glyburide-Metformin Hydrochloride

Product NDC: 10544-579
11-digit product format: 105440579
Labeler code: 10544
Product ID: 10544-579_0f5e4bb2-193d-3a95-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glyburide-Metformin Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA079009
Marketing category: ANDA
Marketing start: 2013-12-20
Marketing end: 0000-00-00
Substance: GLYBURIDE; METFORMIN HYDROCHLORIDE
Active strength: 5 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10544-579		I	Inactivated by FDA	2026-08-11
excluded package	package	10544-579	10544-579-30	I	Inactivated by FDA	2026-08-11
excluded package	package	10544-579	10544-579-90	I	Inactivated by FDA	2026-08-11

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 2 · 66 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	10544-579-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-579-30	`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	10544-579-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-579-30	`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	10544-579-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-579-30	`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	10544-579-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-579-30	`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	10544-579-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-579-30	`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	10544-579-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-579-30	`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	10544-579-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-579-30	`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	10544-579-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-579-30	`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	10544-579-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-579-30	`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	10544-579-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-579-30	`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	10544-579-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-579-30	`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	10544-579-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-579-30	`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	10544-579-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-579-30	`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	10544-579-90	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10544-579-30	`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	10544-579-90	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10544-579-30	`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	10544-579-90	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10544-579-30	`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	10544-579-90	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10544-579-30	`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	10544-579-90	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10544-579-30	`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	10544-579-90	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10544-579-30	`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	10544-579-90	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10544-579-30	`e2bbac7714bc…`	`27bdfed8d636…`

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
A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03
A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03
A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079009-001	AB
A079009-002	AB
A079009-003	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 · 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	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079009-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2009-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079009-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2009-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079009-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2009-06-03	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 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	A079009-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079009-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079009-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079009-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079009-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079009-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079009-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079009-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079009-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079009-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079009-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079009-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079009-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079009-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079009-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079009-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079009-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079009-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079009-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079009-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079009-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079009-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079009-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079009-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079009-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079009-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079009-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079009-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079009-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079009-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079009-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079009-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079009-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079009-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079009-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079009-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079009-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079009-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079009-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079009-001	AB	1	`8072bd15b7f6…`

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
10544-579-30	2020-01-31	C162847	48780-1	9d75b9cf-d5b9-f424-e053-dadaa90a57ce	Rx only
10544-579-90	2020-01-31	C162847	48780-1	9d75b9cf-d5b9-f424-e053-dadaa90a57ce	Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-579-30	Glyburide-Metformin Hydrochloride	30 in 1 BOTTLE	TABLET	30		2
10544-579-90	Glyburide-Metformin Hydrochloride	90 in 1 BOTTLE	TABLET	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-579-30	EA - Each	10544-579	e0c3eeb0-32ce-403a-9a5d-7a596678239a	1	2015-05-05
10544-579-90	EA - Each	10544-579	f8b6ca51-83ed-4d4c-b243-bdcec004a357	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLYBURIDE	ACTIVE INGREDIENT	SX6K58TVWC	GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
GLYBURIDE	ACTIVE MOIETY	SX6K58TVWC	GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
METFORMIN	ACTIVE MOIETY	9100L32L2N	GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
PROPYLENE GLYCOL, (R)-	INACTIVE INGREDIENT	602HN5L69H	GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-579	GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2	Legacy NDC, 2 package rows	20150218_0f530fcd-0ac0-3885-e054-00144ff88e88.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
glyburide-metformin hydrochloride	GLYBURIDE-METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	b5ccf5da-cbe1-4009-ba1c-990050838ee9	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079009 application number: ANDA079009
glyburide-metformin hydrochloride	GLYBURIDE-METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	a086cc29-cb5d-40d0-a57d-8e91f1aa9158	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079009 application number: ANDA079009
glyburide-metformin hydrochloride	GLYBURIDE-METFORMIN HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b38213bb-d663-4c95-a1b2-96c23ee5be09	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079009 application number: ANDA079009
glyburide-metformin hydrochloride	GLYBURIDE-METFORMIN HYDROCHLORIDE	A-S Medication Solutions	f43c087a-7135-4a79-8463-fe5e9319da91	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079009 application number: ANDA079009
glyburide-metformin hydrochloride	GLYBURIDE-METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a0ff8ee6-0da8-40f8-b5b0-a7b334e1a15f	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079009 application number: ANDA079009
glyburide-metformin hydrochloride	GLYBURIDE-METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	486fec17-ff83-3bab-e063-6394a90a5ef0	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079009 application number: ANDA079009
glyburide-metformin hydrochloride	GLYBURIDE-METFORMIN HYDROCHLORIDE	A-S Medication Solutions	faa19e1b-2782-4bf1-a93f-84755f7aa53f	2025-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079009 application number: ANDA079009

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	0f530fcd-0ac0-3885-e054-00144ff88e88	2
861753	glyBURIDE 5 MG / metFORMIN HCl 500 MG Oral Tablet	PSN	0f530fcd-0ac0-3885-e054-00144ff88e88	2
861748	glyburide 2.5 MG / metformin hydrochloride 500 MG Oral Tablet	SCD	0f530fcd-0ac0-3885-e054-00144ff88e88	2
861753	glyburide 5 MG / metformin hydrochloride 500 MG Oral Tablet	SCD	0f530fcd-0ac0-3885-e054-00144ff88e88	2
861753	glyburide 5 MG / metformin HCl 500 MG Oral Tablet	SY	0f530fcd-0ac0-3885-e054-00144ff88e88	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-579-30	10544057930	30 in 1 BOTTLE	Historical
10544-579-90	10544057990	90 in 1 BOTTLE	Historical