Glimepiride

Product NDC: 0093-7256
11-digit product format: 000937256
Labeler code: 0093
Product ID: 0093-7256_909c8f8e-3578-4742-99c5-3895d715d7f0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA076802
Marketing category: ANDA
Marketing start: 2005-10-06
Marketing end: 2020-08-31
Substance: GLIMEPIRIDE
Active strength: 4 mg/1
Pharmacologic classes: Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	0093-7256		D	Discontinued by firm	2026-08-17
excluded package	package	0093-7256	0093-7256-01	D	Discontinued by firm	2026-08-17
excluded package	package	0093-7256	0093-7256-52	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 · 36 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	0093-7256-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0093-7256-52	`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	0093-7256-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0093-7256-52	`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	0093-7256-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0093-7256-52	`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	0093-7256-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0093-7256-52	`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	0093-7256-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0093-7256-52	`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	0093-7256-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0093-7256-52	`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	0093-7256-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0093-7256-52	`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	0093-7256-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0093-7256-52	`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	0093-7256-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0093-7256-52	`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	0093-7256-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0093-7256-52	`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	0093-7256-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0093-7256-52	`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	0093-7256-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0093-7256-52	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	Approval date
A076802-001	GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06
A076802-002	GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06
A076802-003	GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A076802-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076802-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076802-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076802-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076802-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076802-003	AB	1	`ea99ee380514…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-7256-01	EA - Each	0093-7256	dd4296b7-df8f-4cf8-acca-921c3df8d58c	1	2012-07-24
0093-7256-52	EA - Each	0093-7256	d808adf5-7973-47eb-9af0-4d3ffa5b7cfd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLIMEPIRIDE	ACTIVE INGREDIENT	6KY687524K	GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC]	9
GLIMEPIRIDE	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC]	9
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC]	9
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC]	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC]	9
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC]	9
INDIGOTINDISULFONATE SODIUM	INACTIVE INGREDIENT	D3741U8K7L	GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC]	9
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC]	9
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC]	9
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLIMEPIRIDE TABLET [TEVA PHARMACEUTICALS USA INC]	9
GLIMEPIRIDE	ACTIVE INGREDIENT	6KY687524K	GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
GLIMEPIRIDE	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLIMEPIRIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	2

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
199245	glimepiride 1 MG Oral Tablet	PSN	c68bb847-5d17-4d63-99d4-e72f92a31392	2
199246	glimepiride 2 MG Oral Tablet	PSN	c68bb847-5d17-4d63-99d4-e72f92a31392	2
199247	glimepiride 4 MG Oral Tablet	PSN	c68bb847-5d17-4d63-99d4-e72f92a31392	2
199245	glimepiride 1 MG Oral Tablet	SCD	c68bb847-5d17-4d63-99d4-e72f92a31392	2
199246	glimepiride 2 MG Oral Tablet	SCD	c68bb847-5d17-4d63-99d4-e72f92a31392	2
199247	glimepiride 4 MG Oral Tablet	SCD	c68bb847-5d17-4d63-99d4-e72f92a31392	2

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glimepiride	Teva Pharmaceuticals USA, Inc.	2019-02-01	HUMAN PRESCRIPTION DRUG LABEL	14
Glimepiride	QPharma Inc \| Teva Pharmaceuticals USA, Inc. \| Denton Pharma, Inc.	2019-01-10	HUMAN PRESCRIPTION DRUG LABEL	2
GLIMEPIRIDE TABLETS USP 7254 7255 7256 Rx only	Physicians Total Care, Inc.	2010-06-24	HUMAN PRESCRIPTION DRUG LABEL	2