Glimepiride

Product NDC: 0440-6566
11-digit product format: 004406566
Labeler code: 0440
Product ID: 0440-6566_e54a10e9-29e4-4386-9eba-a05559c96bcd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: Liberty Pharmaceuticals, Inc.
Application: ANDA077911
Marketing category: ANDA
Marketing start: 2012-01-01
Marketing end: 0000-00-00
Substance: GLIMEPIRIDE
Active strength: 4 mg/1
Pharmacologic classes: Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
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	0440-6566		I	Inactivated by FDA		2026-08-17
excluded package	package	0440-6566	0440-6566-01	I	Inactivated by FDA		2026-08-17

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	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0440-6566-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0440-6566-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0440-6566-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0440-6566-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0440-6566-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0440-6566-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0440-6566-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0440-6566-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0440-6566-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0440-6566-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0440-6566-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0440-6566-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0440-6566-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0440-6566-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0440-6566-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0440-6566-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0440-6566-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0440-6566-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0440-6566-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0440-6566-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0440-6566-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0440-6566-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077911-001	GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22
A077911-002	GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22
A077911-003	GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077911-001	AB
A077911-002	AB
A077911-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077911-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077911-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077911-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077911-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077911-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077911-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077911-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077911-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077911-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077911-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077911-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077911-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077911-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077911-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077911-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077911-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077911-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077911-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077911-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077911-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077911-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077911-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077911-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077911-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077911-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077911-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077911-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077911-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077911-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077911-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077911-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077911-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077911-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077911-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077911-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077911-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077911-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077911-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077911-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077911-001	AB	1	`1e350fbaab3a…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b890b964-2cf0-4439-aaf3-900c9e3e9e49	Product name	1	20160602
7611093e-8875-33d4-9e3c-f48c7e3af1e8	Product name	1	20140508
d36d861f-8a90-80cc-8935-1e6be9b4c7eb	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0440-6566-01	2020-01-31	C162847	48780-1	9d75b9d0-4c30-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Glimepiride safely and effectively. See full prescribing information for Glimepiride Tablets, USP. Glimepiride Tablets, USP Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0440-6566-01	Glimepiride	100 in 1 BOTTLE	TABLET	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0440-6566	GLIMEPIRIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]	2	Legacy NDC, 1 package rows	20160805_57d6c173-0ef2-44a1-962e-4df021481c79.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	647a146c-c752-4589-8619-aed5c720ca54	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077911 application number: ANDA077911
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	ed7a3a8e-97dd-4a5a-9497-001acfd2f1f0	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077911 application number: ANDA077911
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	f4ffb19e-6d65-49fd-83ce-514d38d9d97c	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077911 application number: ANDA077911
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	11ae3189-6139-4470-95d5-72abc0f5b0d0	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077911 application number: ANDA077911
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	2794f86b-d521-414b-8154-5dd1e2519653	2025-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077911 application number: ANDA077911
Glimepiride	GLIMEPIRIDE	Golden State Medical Supply, Inc.	4f83e203-c102-47fa-bb8e-4fc5541e0d6f	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077911 application number: ANDA077911
Glimepiride	GLIMEPIRIDE	Carlsbad Technology, Inc.	72d88c6d-2f0a-4bf8-aa7f-1e1811794187	2024-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077911 application number: ANDA077911
Glimepiride	GLIMEPIRIDE	Aphena Pharma Solutions - Tennessee, LLC	00b9e312-921e-41e6-ad27-0a6ce87f8298	2019-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077911 application number: ANDA077911

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6KY687524K	GLIMEPIRIDE	93479-97-1	GLIMEPIRIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199247	glimepiride 4 MG Oral Tablet	PSN	57d6c173-0ef2-44a1-962e-4df021481c79	2
199247	glimepiride 4 MG Oral Tablet	SCD	57d6c173-0ef2-44a1-962e-4df021481c79	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
0440-6566-01	00440656601	100 in 1 BOTTLE	Historical