Glimepiride

Product NDC: 68001-178
11-digit product format: 680010178
Labeler code: 68001
Product ID: 68001-178_eff41a95-d73d-ed0a-e053-2995a90acfc9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA078181
Marketing category: ANDA
Marketing start: 2014-02-26
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#

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	68001-178		D	Discontinued by firm	2026-08-17
excluded package	package	68001-178	68001-178-00	D	Discontinued by firm	2026-08-17
excluded package	package	68001-178	68001-178-03	D	Discontinued by firm	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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	68001-178		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68001-178	68001-178-00	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68001-178	68001-178-03	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
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 · 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	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`caaa826d4ba7…`
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…`

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	A078181-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078181-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078181-003	AB	1	`caaa826d4ba7…`
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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-178-00	EA - Each	68001-178	ee560ea0-177c-40c8-b3c8-002f352992d3	1	2014-05-02
68001-178-03	EA - Each	68001-178	65e5f814-dbf0-426b-a0ab-d031e3cc6b4c	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
glimepiride	ACTIVE INGREDIENT	6KY687524K	GLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]	4
glimepiride	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	GLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]	4
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	GLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]	4
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	GLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]	4
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]	4
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	GLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	GLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]	4
sodium starch glycolate type a potato	INACTIVE INGREDIENT	5856J3G2A2	GLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-178	GLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]	13	Legacy NDC	20240223_d162c78f-d176-4150-8dda-2c4a5d215014.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 · 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

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
68001-178-00	68001017800	100 TABLET in 1 BOTTLE (68001-178-00)	100 tablet	2014-02-26	0000-00-00	No	No	Current
68001-178-03	68001017803	500 TABLET in 1 BOTTLE (68001-178-03)	500 tablet	2014-02-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glimepiride	BluePoint Laboratories \| Accord Healthcare, Inc \| Intas Pharmaceuticals Limited	2024-02-21	HUMAN PRESCRIPTION DRUG LABEL	13