Glimepiride

Product NDC: 50090-6852
11-digit product format: 500906852
Labeler code: 50090
Product ID: 50090-6852_9586a5f8-3644-4a45-bb30-f36e87f71154
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA077091
Marketing category: ANDA
Marketing start: 2005-10-06
Substance: GLIMEPIRIDE
Active strength: 4 mg/1
Pharmacologic classes: Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 ndc (product): 50090-6852
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

Additional Listing Data#

Finished product: Yes
Brand name base: Glimepiride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLIMEPIRIDE	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6KY687524K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199247	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a9461830-1c4f-4bc4-b622-1c44112a76b9	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-6852-0	Glimepiride	90 in 1 BOTTLE	TABLET	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6852-0	EA - Each	50090-6852	bb1ad583-30c2-4e3b-9ea0-91b50a34ea8d	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6852	GLIMEPIRIDE TABLET [A-S MEDICATION SOLUTIONS]	1	Current NDC, 1 package rows	20231204_a9461830-1c4f-4bc4-b622-1c44112a76b9.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	a9461830-1c4f-4bc4-b622-1c44112a76b9	1
199247	glimepiride 4 MG Oral Tablet	SCD	a9461830-1c4f-4bc4-b622-1c44112a76b9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-6852-0	50090685200	90 TABLET in 1 BOTTLE (50090-6852-0)	90 tablet	2023-11-29	No	No	Current