Glimepiride

Product NDC: 33261-892
11-digit product format: 332610892
Labeler code: 33261
Product ID: 33261-892_0bbcdb96-76b4-4d74-a385-9ead00baa8ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA077091
Marketing category: ANDA
Marketing start: 2005-10-06
Marketing end: 0000-00-00
Substance: GLIMEPIRIDE
Active strength: 4 mg/1
Pharmacologic classes: Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	33261-892		I	Inactivated by FDA	2026-07-31
excluded package	package	33261-892	33261-892-30	I	Inactivated by FDA	2026-07-31
excluded package	package	33261-892	33261-892-60	I	Inactivated by FDA	2026-07-31
excluded package	package	33261-892	33261-892-90	I	Inactivated by FDA	2026-07-31
excluded package	package	33261-892	33261-892-99	I	Inactivated by FDA	2026-07-31

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	RLD / RS	Approval date
A077091-001	GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	RS	2005-10-06
A077091-002	GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06
A077091-003	GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077091-001	AB
A077091-002	AB
A077091-003	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	RS	2005-10-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A077091-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077091-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077091-003	AB	1	`a50c72e98297…`

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glimepiride	GLIMEPIRIDE	Cardinal Health 107, LLC	cc2bc07f-3fab-4df1-85cc-dc0c8e60b4fa	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	NuCare Pharmaceuticals,Inc.	bf8e5993-5ee7-d26d-e053-2a95a90ae5df	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	AvPAK	93f1e064-fcbd-e8fd-e053-2995a90a5dbb	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	Northwind Health Company, LLC	f3184cd3-df99-db32-e053-2995a90aa573	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	Northwind Health Company, LLC	dae404ac-881a-14d8-e053-2995a90acd41	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	101cdc41-2131-4425-b550-6a0a60b5f4a4	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	657f1b51-2f82-44f6-a23d-97f4b34b3c45	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	American Health Packaging	0003458f-352a-46fa-9d99-230daa76ae29	2024-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	1f102e4c-1954-4f17-8c60-4dad79f25a25	2024-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	NuCare Pharmaceuticals,Inc.	abc187f1-8645-23e9-e053-2a95a90a64a7	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	be772fca-1579-4fba-a4b7-04b970d09e45	2023-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	0a1eaf23-d5fd-4b3e-96c5-68ff16f0033b	2023-12-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	a9461830-1c4f-4bc4-b622-1c44112a76b9	2023-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	def20e38-01f7-4ead-beb6-3dc11062a342	2023-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	ebb9f080-b11d-5d18-36f0-627107e7fbcd	2020-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	Dr. Reddy's Laboratories Limited	07ad4366-4b21-f633-49f3-c2b35f88168d	2019-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091

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
33261-892-30	2020-01-31	C162847	48780-1	9d75b9d0-a21f-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. Glimepiride Tablets USP for oral use Initial U.S. Approval: 1995
33261-892-60	2020-01-31	C162847	48780-1	9d75b9d0-a21f-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. Glimepiride Tablets USP for oral use Initial U.S. Approval: 1995
33261-892-90	2020-01-31	C162847	48780-1	9d75b9d0-a21f-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. Glimepiride Tablets USP for oral use Initial U.S. Approval: 1995
33261-892-99	2020-01-31	C162847	48780-1	9d75b9d0-a21f-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. Glimepiride Tablets USP for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
33261-892-30	Glimepiride	30 in 1 BOTTLE, PLASTIC	TABLET	30	1
33261-892-60	Glimepiride	60 in 1 BOTTLE, PLASTIC	TABLET	60	1
33261-892-90	Glimepiride	90 in 1 BOTTLE, PLASTIC	TABLET	90	1
33261-892-99	Glimepiride	180 in 1 BOTTLE, PLASTIC	TABLET	180	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-892-30	EA - Each	33261-892	a019e4ab-45bb-469c-9ce0-e73b484bf0dc	1	2015-10-02
33261-892-60	EA - Each	33261-892	db19ac26-0523-4e79-adc7-4473a999e0bd	1	2015-10-02
33261-892-90	EA - Each	33261-892	c85ff86c-6df2-4d4d-b3e1-9413ba6b0f71	1	2015-10-02
33261-892-99	EA - Each	33261-892	cf6504c1-9ceb-4c2d-8430-81d1198a9d3f	1	2016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLIMEPIRIDE	ACTIVE INGREDIENT	6KY687524K	GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
GLIMEPIRIDE	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-892	GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 4 package rows	20140110_9275a6af-b7f2-4d1a-b412-14a3c611e6f8.zip

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	9275a6af-b7f2-4d1a-b412-14a3c611e6f8	1
199247	glimepiride 4 MG Oral Tablet	SCD	9275a6af-b7f2-4d1a-b412-14a3c611e6f8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33261-892-30	33261089230	30 in 1 BOTTLE, PLASTIC	Historical
33261-892-60	33261089260	60 in 1 BOTTLE, PLASTIC	Historical
33261-892-90	33261089290	90 in 1 BOTTLE, PLASTIC	Historical
33261-892-99	33261089299	180 in 1 BOTTLE, PLASTIC	Historical