Glimepiride

Product NDC: 68788-8432
11-digit product format: 687888432
Labeler code: 68788
Product ID: 68788-8432_3da4957f-9f52-48f4-8182-1d9a6c292358
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA202759
Marketing category: ANDA
Marketing start: 2023-04-27
Substance: GLIMEPIRIDE
Active strength: 4 mg/1
Pharmacologic classes: Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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	Approval date
A202759-001	GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29
A202759-002	GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29
A202759-003	GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202759-001	AB
A202759-002	AB
A202759-003	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`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	A202759-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202759-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202759-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202759-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202759-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202759-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202759-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202759-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202759-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202759-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202759-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202759-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202759-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202759-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202759-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202759-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202759-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202759-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202759-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202759-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202759-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202759-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202759-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202759-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202759-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202759-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202759-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202759-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202759-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202759-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202759-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202759-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202759-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202759-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202759-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202759-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202759-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202759-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202759-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202759-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Glimepiride
Listing expiration: 2027-12-31

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
744a5cca-7863-491a-b43a-1b649791702c	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
68788-8432-3	Glimepiride	30 in 1 BOTTLE	TABLET	30	4
68788-8432-6	Glimepiride	60 in 1 BOTTLE	TABLET	60	4
68788-8432-9	Glimepiride	90 in 1 BOTTLE	TABLET	90	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8432-3	EA - Each	68788-8432	15ea476c-424d-4989-88a4-dacef08ce286	1	2023-06-06
68788-8432-6	EA - Each	68788-8432	a8b49520-88f3-4717-a437-ac1a7d4d52d3	1	2023-06-06
68788-8432-9	EA - Each	68788-8432	8cd786d8-e9f2-4cd4-bee5-8310e8a3ab93	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8432	GLIMEPIRIDE TABLET [PREFERRED PHARMACEUTICALS INC.]	2	Current NDC, 3 package rows	20240511_744a5cca-7863-491a-b43a-1b649791702c.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glimepiride	GLIMEPIRIDE	St. Mary's Medical Park Pharmacy	fc9d8495-184c-3af1-e053-6394a90a5e29	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Preferred Pharmaceuticals Inc.	744a5cca-7863-491a-b43a-1b649791702c	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759 ndc (product): 68788-8432
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	248c3cb3-4501-4b85-bd1d-0624b6afda2c	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	90d675cb-6def-49a3-b8b4-229f19d6b617	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Aurobindo Pharma Limited	28eefc95-d92e-4555-b6c5-2933860b0610	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	1450f455-a14a-4f9b-b3aa-dae49ea0c186	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	dbed06f9-7758-4c96-9af0-1ed6103db7df	2026-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	e12ab052-e3d6-4246-b727-f1e3f9057f09	2026-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Rising Pharma Holdings, Inc.	48ada723-8144-497d-afd6-a8c52a1dd3ff	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	b6ce0eea-149d-4aed-a615-0b1c8f3f6a8e	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Northwind Health Company, LLC	10a36c79-1b24-46b7-e063-6294a90a8dca	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	489dc098-0ac7-4f8e-b258-326229539c7c	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	be7175ae-ba53-45b8-9554-e4f4ebf56883	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Direct_Rx	fd26934e-daea-f47b-e053-6394a90a4bc6	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	a11680ba-2750-43ab-a1b1-a52ebe3e139f	2023-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	e8da2484-43a7-4dcb-84d5-d84596feb9f6	2023-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	8f687fa6-54eb-4556-8ea6-aafec49a87d1	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759

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	744a5cca-7863-491a-b43a-1b649791702c	4
199247	glimepiride 4 MG Oral Tablet	SCD	744a5cca-7863-491a-b43a-1b649791702c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8432-3	68788843203	30 TABLET in 1 BOTTLE (68788-8432-3)	30 tablet	2023-04-27	No	No	Current
68788-8432-6	68788843206	60 TABLET in 1 BOTTLE (68788-8432-6)	60 tablet	2023-04-27	No	No	Current
68788-8432-9	68788843209	90 TABLET in 1 BOTTLE (68788-8432-9)	90 tablet	2023-04-27	No	No	Current