Glimepiride

Product NDC: 0615-8334
11-digit product format: 006158334
Labeler code: 0615
Product ID: 0615-8334_18f8ad9b-20d5-47ea-ad3a-9b2a7e3a4dd8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA091220
Marketing category: ANDA
Marketing start: 2013-06-13
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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091220-001	GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29
A091220-002	GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29
A091220-003	GLIMEPIRIDE	GLIMEPIRIDE	3MG	TABLET / ORAL		2012-06-29
A091220-004	GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29
A091220-005	GLIMEPIRIDE	GLIMEPIRIDE	6MG	TABLET / ORAL		2012-06-29
A091220-006	GLIMEPIRIDE	GLIMEPIRIDE	8MG	TABLET / ORAL	AB	2012-06-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A091220-001	AB
A091220-002	AB
A091220-004	AB
A091220-006	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 7 · 252 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	A091220-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091220-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091220-003	GLIMEPIRIDE	3MG	TABLET / ORAL		2012-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091220-004	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091220-005	GLIMEPIRIDE	6MG	TABLET / ORAL		2012-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091220-006	GLIMEPIRIDE	8MG	TABLET / ORAL	AB	2012-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091220-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091220-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091220-003	GLIMEPIRIDE	3MG	TABLET / ORAL		2012-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091220-004	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091220-005	GLIMEPIRIDE	6MG	TABLET / ORAL		2012-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091220-006	GLIMEPIRIDE	8MG	TABLET / ORAL	AB	2012-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091220-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091220-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091220-003	GLIMEPIRIDE	3MG	TABLET / ORAL		2012-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091220-004	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091220-005	GLIMEPIRIDE	6MG	TABLET / ORAL		2012-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091220-006	GLIMEPIRIDE	8MG	TABLET / ORAL	AB	2012-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091220-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091220-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091220-003	GLIMEPIRIDE	3MG	TABLET / ORAL		2012-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091220-004	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091220-005	GLIMEPIRIDE	6MG	TABLET / ORAL		2012-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091220-006	GLIMEPIRIDE	8MG	TABLET / ORAL	AB	2012-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091220-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091220-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091220-003	GLIMEPIRIDE	3MG	TABLET / ORAL		2012-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091220-004	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091220-005	GLIMEPIRIDE	6MG	TABLET / ORAL		2012-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091220-006	GLIMEPIRIDE	8MG	TABLET / ORAL	AB	2012-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091220-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091220-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091220-003	GLIMEPIRIDE	3MG	TABLET / ORAL		2012-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091220-004	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091220-005	GLIMEPIRIDE	6MG	TABLET / ORAL		2012-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091220-006	GLIMEPIRIDE	8MG	TABLET / ORAL	AB	2012-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091220-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091220-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091220-003	GLIMEPIRIDE	3MG	TABLET / ORAL		2012-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091220-004	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A091220-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091220-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091220-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091220-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091220-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091220-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091220-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091220-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091220-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091220-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091220-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091220-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091220-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091220-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091220-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091220-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091220-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091220-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091220-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091220-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091220-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091220-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091220-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091220-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091220-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091220-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091220-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091220-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091220-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091220-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091220-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091220-006	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091220-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091220-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091220-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091220-006	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091220-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091220-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091220-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091220-006	AB	1	`d8e5a09893c0…`

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 · 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
669a67c2-2f97-4b7e-8bba-83a015e0fa94	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
0615-8334-39	Glimepiride	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-8334	GLIMEPIRIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1	Current NDC, Legacy NDC, 1 package rows	20200505_669a67c2-2f97-4b7e-8bba-83a015e0fa94.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	62780d2e-083d-4bcb-99ff-1b1b4ade60d9	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091220 application number: ANDA091220
Glimepiride	GLIMEPIRIDE	BluePoint Laboratories	a01b0466-13f5-4c47-ae55-c5f1527d9414	2025-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091220 application number: ANDA091220
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	d4513181-4558-4d9a-851b-acf7e3eda25a	2025-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091220 application number: ANDA091220
Glimepiride	GLIMEPIRIDE	Micro Labs Limited	60e9397e-83b9-489e-9683-6f87e458bbaa	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091220 application number: ANDA091220
Glimepiride 3 mg	GLIMEPIRIDE	Lifsa Drugs LLC	51157849-7990-4a8b-ae50-eda1baf93cfa	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091220 application number: ANDA091220
Glimepiride	GLIMEPIRIDE	NCS HealthCare of KY, Inc dba Vangard Labs	669a67c2-2f97-4b7e-8bba-83a015e0fa94	2020-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091220 application number: ANDA091220 ndc (product): 0615-8334

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
199245	glimepiride 1 MG Oral Tablet	PSN	669a67c2-2f97-4b7e-8bba-83a015e0fa94	1
199246	glimepiride 2 MG Oral Tablet	PSN	669a67c2-2f97-4b7e-8bba-83a015e0fa94	1
199247	glimepiride 4 MG Oral Tablet	PSN	669a67c2-2f97-4b7e-8bba-83a015e0fa94	1
199245	glimepiride 1 MG Oral Tablet	SCD	669a67c2-2f97-4b7e-8bba-83a015e0fa94	1
199246	glimepiride 2 MG Oral Tablet	SCD	669a67c2-2f97-4b7e-8bba-83a015e0fa94	1
199247	glimepiride 4 MG Oral Tablet	SCD	669a67c2-2f97-4b7e-8bba-83a015e0fa94	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0615-8334-39	00615833439	30 TABLET in 1 BLISTER PACK (0615-8334-39)	30 tablet	2020-04-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glimepiride	NCS HealthCare of KY, Inc dba Vangard Labs	2020-04-30	HUMAN PRESCRIPTION DRUG LABEL	1