Glimepiride

Product NDC: 72789-048
11-digit product format: 727890048
Labeler code: 72789
Product ID: 72789-048_2d5911d5-5d70-cd46-e063-6394a90a2660
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA077911
Marketing category: ANDA
Marketing start: 2012-01-01
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	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.

Product history page 1 of 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077911-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2009-09-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077911-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2009-09-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077911-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2009-09-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077911-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077911-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077911-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077911-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077911-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077911-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077911-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077911-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077911-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077911-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077911-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077911-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077911-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077911-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077911-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077911-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077911-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077911-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077911-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077911-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077911-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077911-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077911-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077911-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077911-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077911-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077911-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077911-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077911-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077911-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077911-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077911-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077911-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077911-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077911-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077911-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077911-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077911-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077911-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077911-001	AB	1	`8072bd15b7f6…`

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
f4ffb19e-6d65-49fd-83ce-514d38d9d97c	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
72789-048-30	Glimepiride	30 in 1 BOTTLE, PLASTIC	TABLET	30		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-048-30	EA - Each	72789-048	5da1cf3a-b89a-4360-a4ca-6d03dfd06460	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-048	GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	15	Current NDC, Legacy NDC, 1 package rows	20250206_f4ffb19e-6d65-49fd-83ce-514d38d9d97c.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 · 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 ndc (product): 72789-048
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
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

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	f4ffb19e-6d65-49fd-83ce-514d38d9d97c	15
199247	glimepiride 4 MG Oral Tablet	SCD	f4ffb19e-6d65-49fd-83ce-514d38d9d97c	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-048-30	72789004830	30 TABLET in 1 BOTTLE, PLASTIC (72789-048-30)	30 tablet	2020-01-12	0000-00-00	No	No	Current