Glimepiride

Product NDC: 68071-2228
11-digit product format: 680712228
Labeler code: 68071
Product ID: 68071-2228_1d7632a7-0f26-9e5d-e063-6294a90ad21f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
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 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	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.

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	RS	2005-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	RS	2005-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	RS	2005-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	RS	2005-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	RS	2005-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB		2005-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB		2005-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB		2005-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB		2005-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB		2005-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB		2005-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB		2005-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB		2005-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB		2005-10-06	`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	A077091-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077091-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077091-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077091-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077091-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077091-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077091-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077091-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077091-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077091-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077091-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077091-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077091-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077091-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077091-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077091-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077091-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077091-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077091-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077091-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077091-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077091-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077091-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077091-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077091-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077091-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077091-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077091-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077091-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077091-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077091-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077091-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077091-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077091-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077091-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077091-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077091-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077091-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077091-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077091-001	AB	1	`1e350fbaab3a…`

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
abc187f1-8645-23e9-e053-2a95a90a64a7	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
68071-2228-6	Glimepiride	60 in 1 BOTTLE	TABLET	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2228	GLIMEPIRIDE TABLET [NUCARE PHARMACEUTICALS,INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240719_abc187f1-8645-23e9-e053-2a95a90a64a7.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 · 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 ndc (product): 68071-2228
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

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	abc187f1-8645-23e9-e053-2a95a90a64a7	3
199247	glimepiride 4 MG Oral Tablet	SCD	abc187f1-8645-23e9-e053-2a95a90a64a7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2228-6	68071222806	60 TABLET in 1 BOTTLE (68071-2228-6)	60 tablet	2020-07-31	0000-00-00	No	No	Current