Glimepiride

Product NDC: 50090-2486
Requested package NDC: 50090-2486-4
11-digit product format: 500902486
Labeler code: 50090
Product ID: 50090-2486_849fb560-7b22-4277-bd53-b508ef6f859e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA077911
Marketing category: ANDA
Marketing start: 2012-01-01
Marketing end: 0000-00-00
Substance: GLIMEPIRIDE
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

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	50090-2486	50090-2486-4	D	Discontinued by firm		2026-08-03

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 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
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 · 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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077911-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077911-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077911-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-2486-0	EA - Each	50090-2486	8b52120d-4f35-4212-8943-2e21306d4902	1	2019-03-12
50090-2486-1	EA - Each	50090-2486	55fb085c-e109-4349-ac05-2e20d2d75a7f	1	2019-03-12
50090-2486-3	EA - Each	50090-2486	1715e804-504f-4d0f-b93a-3bbf65edda05	1	2019-03-12
50090-2486-4	EA - Each	50090-2486	6117a88d-0bfd-42ab-bd1f-5a926dc05e54	1	2019-05-02

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-2486-4	50090248604	180 TABLET in 1 BOTTLE, PLASTIC (50090-2486-4)	180 tablet	2014-11-28	0000-00-00	No	No	Current