Glimepiride

Product NDC: 61442-116
11-digit product format: 614420116
Labeler code: 61442
Product ID: 61442-116_2386d706-9dab-4ae0-e063-6394a90a8a06
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: Carlsbad Technology, Inc.
Application: ANDA077911
Marketing category: ANDA
Marketing start: 2012-01-01
Substance: GLIMEPIRIDE
Active strength: 2 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	Approval date
A077911-001	GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22
A077911-002	GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22
A077911-003	GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077911-001	AB
A077911-002	AB
A077911-003	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	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`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	A077911-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077911-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077911-003	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	647a146c-c752-4589-8619-aed5c720ca54	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077911 application number: ANDA077911
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	ed7a3a8e-97dd-4a5a-9497-001acfd2f1f0	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077911 application number: ANDA077911
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	f4ffb19e-6d65-49fd-83ce-514d38d9d97c	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077911 application number: ANDA077911
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	11ae3189-6139-4470-95d5-72abc0f5b0d0	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077911 application number: ANDA077911
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	2794f86b-d521-414b-8154-5dd1e2519653	2025-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077911 application number: ANDA077911
Glimepiride	GLIMEPIRIDE	Golden State Medical Supply, Inc.	4f83e203-c102-47fa-bb8e-4fc5541e0d6f	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077911 application number: ANDA077911
Glimepiride	GLIMEPIRIDE	Carlsbad Technology, Inc.	72d88c6d-2f0a-4bf8-aa7f-1e1811794187	2024-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077911 application number: ANDA077911 ndc (product): 61442-116
Glimepiride	GLIMEPIRIDE	Aphena Pharma Solutions - Tennessee, LLC	00b9e312-921e-41e6-ad27-0a6ce87f8298	2019-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077911 application number: ANDA077911

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLIMEPIRIDE	2 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199245	Internal RxNorm lookup
199246	Internal RxNorm lookup
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
72d88c6d-2f0a-4bf8-aa7f-1e1811794187	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	SPL version
61442-116-01	Glimepiride	100 in 1 BOTTLE	TABLET	100	11
61442-116-05	Glimepiride	500 in 1 BOTTLE	TABLET	500	11
61442-116-10	Glimepiride	1000 in 1 BOTTLE	TABLET	1000	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61442-116-01	EA - Each	61442-116	dea3704e-f1cb-4652-8408-29176dbc0a2d	1	2012-07-24
61442-116-05	EA - Each	61442-116	09b98cc6-beb7-4ce3-8418-dc5d0c65aa8a	1	2016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLIMEPIRIDE	ACTIVE INGREDIENT	6KY687524K	GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.]	7
GLIMEPIRIDE	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.]	7
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.]	7
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.]	7
GLIMEPIRIDE	ACTIVE INGREDIENT	6KY687524K	GLIMEPIRIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
GLIMEPIRIDE	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61442-116	GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.]	11	Current NDC, Legacy NDC, 3 package rows	20241004_72d88c6d-2f0a-4bf8-aa7f-1e1811794187.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
199246	glimepiride 2 MG Oral Tablet	PSN	11ae3189-6139-4470-95d5-72abc0f5b0d0	22
199246	glimepiride 2 MG Oral Tablet	SCD	11ae3189-6139-4470-95d5-72abc0f5b0d0	22
199246	glimepiride 2 MG Oral Tablet	PSN	2794f86b-d521-414b-8154-5dd1e2519653	16
199246	glimepiride 2 MG Oral Tablet	SCD	2794f86b-d521-414b-8154-5dd1e2519653	16
199245	glimepiride 1 MG Oral Tablet	PSN	72d88c6d-2f0a-4bf8-aa7f-1e1811794187	11
199246	glimepiride 2 MG Oral Tablet	PSN	72d88c6d-2f0a-4bf8-aa7f-1e1811794187	11
199247	glimepiride 4 MG Oral Tablet	PSN	72d88c6d-2f0a-4bf8-aa7f-1e1811794187	11
199245	glimepiride 1 MG Oral Tablet	SCD	72d88c6d-2f0a-4bf8-aa7f-1e1811794187	11
199246	glimepiride 2 MG Oral Tablet	SCD	72d88c6d-2f0a-4bf8-aa7f-1e1811794187	11
199247	glimepiride 4 MG Oral Tablet	SCD	72d88c6d-2f0a-4bf8-aa7f-1e1811794187	11
199245	glimepiride 1 MG Oral Tablet	PSN	4f83e203-c102-47fa-bb8e-4fc5541e0d6f	6
199246	glimepiride 2 MG Oral Tablet	PSN	4f83e203-c102-47fa-bb8e-4fc5541e0d6f	6
199247	glimepiride 4 MG Oral Tablet	PSN	4f83e203-c102-47fa-bb8e-4fc5541e0d6f	6
199245	glimepiride 1 MG Oral Tablet	SCD	4f83e203-c102-47fa-bb8e-4fc5541e0d6f	6
199246	glimepiride 2 MG Oral Tablet	SCD	4f83e203-c102-47fa-bb8e-4fc5541e0d6f	6
199247	glimepiride 4 MG Oral Tablet	SCD	4f83e203-c102-47fa-bb8e-4fc5541e0d6f	6
199246	glimepiride 2 MG Oral Tablet	PSN	8b309577-5461-43eb-bb0b-0a5293ee9392	2
199246	glimepiride 2 MG Oral Tablet	PSN	5659e616-4858-4543-8e0b-c5477519f8fe	2
199246	glimepiride 2 MG Oral Tablet	SCD	8b309577-5461-43eb-bb0b-0a5293ee9392	2
199246	glimepiride 2 MG Oral Tablet	SCD	5659e616-4858-4543-8e0b-c5477519f8fe	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61442-116-01	61442011601	100 TABLET in 1 BOTTLE (61442-116-01)	100 tablet	2012-01-01	0000-00-00	No	No	Current
61442-116-05	61442011605	500 TABLET in 1 BOTTLE (61442-116-05)	500 tablet	2012-01-01	0000-00-00	No	No	Current
61442-116-10	61442011610	1000 TABLET in 1 BOTTLE (61442-116-10)	1000 tablet	2012-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glimepiride	REMEDYREPACK INC.	2025-09-29	HUMAN PRESCRIPTION DRUG LABEL	2
Glimepiride	PD-Rx Pharmaceuticals, Inc.	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	22
Glimepiride	PD-Rx Pharmaceuticals, Inc.	2025-01-03	HUMAN PRESCRIPTION DRUG LABEL	16
Glimepiride	Golden State Medical Supply, Inc.	2024-12-05	HUMAN PRESCRIPTION DRUG LABEL	6
Glimepiride	Carlsbad Technology, Inc.	2024-10-02	HUMAN PRESCRIPTION DRUG LABEL	11
Glimepiride	A-S Medication Solutions	2019-04-30	HUMAN PRESCRIPTION DRUG LABEL	7
Glimepiride	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-05-31	HUMAN PRESCRIPTION DRUG LABEL	2
Glimepiride	Liberty Pharmaceuticals, Inc.	2016-08-03	HUMAN PRESCRIPTION DRUG LABEL	2
GLIMEPIRIDE	Northwind Pharmaceuticals, LLC	2015-03-24	HUMAN PRESCRIPTION DRUG LABEL	1