Glimepiride

Product NDC: 68788-8095
Requested package NDC: 68788-8095-9
11-digit product format: 687888095
Labeler code: 68788
Product ID: 68788-8095_81d7aee5-2233-46b9-b044-441457f82cde
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA078181
Marketing category: ANDA
Marketing start: 2021-10-06
Marketing end: 0000-00-00
Substance: GLIMEPIRIDE
Active strength: 2 mg/1
Pharmacologic classes: Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	68788-8095	68788-8095-9	D	Discontinued by firm		2026-08-03

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
A078181-001	GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23
A078181-002	GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23
A078181-003	GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078181-001	AB
A078181-002	AB
A078181-003	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	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`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	A078181-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078181-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078181-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078181-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078181-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078181-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078181-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078181-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078181-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078181-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078181-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078181-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078181-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078181-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078181-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078181-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078181-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078181-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078181-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078181-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078181-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078181-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078181-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078181-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078181-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078181-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078181-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078181-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078181-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078181-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078181-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078181-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078181-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078181-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078181-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078181-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078181-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078181-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078181-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078181-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	9e863f84-d6f2-4d61-8250-774569e84353	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	58c4261e-e98f-4280-9562-2800956dff14	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	1b3c7d74-f80b-4fb1-8dca-66880af5d3fc	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	Northwind Health Company, LLC	3e81a39a-30bb-4d6d-82e1-17d7134365be	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	Northwind Health Company, LLC	f2f2d6da-eb40-4290-e053-2a95a90a6ca0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	Accord Healthcare Inc	9b74fbac-9e04-4927-9981-1e3dace89c6d	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	beb0cefb-807b-4cc3-ada2-7a8ed4aa8f2b	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	5a5747ea-cded-49ed-8807-dd3e2a1159e0	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	68cb4fcd-5bc3-4f53-9085-86df6a4246d6	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8095-1	EA - Each	68788-8095	ff7d6412-9ee6-4b5d-ac22-2f375789ae42	1	2021-11-09
68788-8095-3	EA - Each	68788-8095	ff861eb7-dcf0-4a2e-bf98-73f1e252101d	1	2021-11-09
68788-8095-6	EA - Each	68788-8095	5bc8011e-998b-4a8f-b6f3-d4d8c99e6d5f	1	2021-11-09
68788-8095-9	EA - Each	68788-8095	1b99cb97-423b-472f-951d-b49728c1d46a	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8095	GLIMEPIRIDE TABLET [PREFERRED PHARMACEUTICALS INC.]	4	Legacy NDC	20240511_8ba135eb-bfb4-4cc2-a8c9-8f750ca3e807.zip

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
68788-8095-9	68788809509	90 TABLET in 1 BOTTLE (68788-8095-9)	90 tablet	2021-10-06	0000-00-00	No	No	Current