Glimepiride

Product NDC: 67046-1608
Requested package NDC: 67046-1608-3
11-digit product format: 670461608
Labeler code: 67046
Product ID: 67046-1608_48c0ccac-2fbc-0fe2-e063-6294a90a2a9c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA202112
Marketing category: ANDA
Marketing start: 2025-10-22
Substance: GLIMEPIRIDE
Active strength: 2 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 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
A202112-001	GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17
A202112-002	GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17
A202112-003	GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202112-001	AB
A202112-002	AB
A202112-003	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	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`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	A202112-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202112-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202112-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202112-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202112-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202112-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202112-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202112-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202112-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202112-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202112-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202112-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202112-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202112-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202112-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202112-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202112-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202112-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202112-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202112-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202112-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202112-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202112-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202112-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202112-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202112-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202112-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202112-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202112-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202112-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202112-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202112-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202112-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202112-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202112-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202112-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202112-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202112-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202112-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202112-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199246	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
41bf4a72-9288-50a1-e063-6394a90a5e7c	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
67046-1608-3	Glimepiride	30 in 1 BLISTER PACK	TABLET	30		2

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	Preferred Pharmaceuticals Inc.	f69e36b9-4940-4f01-b5ea-59dc66dc1e87	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	Coupler LLC	41bf4a72-9288-50a1-e063-6394a90a5e7c	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112 ndc (package): 67046-1608-3 ndc (product): 67046-1608 ndc11 (package): 67046160803
Glimepiride	GLIMEPIRIDE	REMEDYREPACK INC.	c994796e-dd3d-4f40-a8f2-d317f55e34d5	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	REMEDYREPACK INC.	95c59026-a2db-4579-b58c-b0a8e12e7f84	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	ST. MARY'S MEDICAL PARK PHARMACY	35ba31ef-2b90-61c6-e063-6394a90a59ee	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	49bf2d48-efa8-487b-b861-0124c3a4c951	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	661b5b13-6334-4965-8dc5-709e19080584	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	0c25c987-856f-448d-903a-e2c94049b0a7	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	79ee7533-f75d-4c49-b396-b339654f5c44	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	Florida Pharmaceutical Products, LLC	8ff0de99-272e-4e68-9caf-69f3f146ac29	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	Direct_rx	230949fd-563e-8dbf-e063-6394a90ab9b6	2024-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	1e5d562e-b3bf-4502-adc8-c89c8818a9bc	2024-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	01196f54-32c8-41a0-b0ed-7968ca5d2fa2	2024-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	NuCare Pharmaceuticals,Inc.	1c335fc7-24d0-5526-e063-6394a90a488e	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	0b12d4ab-fa0c-44d5-888c-265dbb661561	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	cdeda274-955b-413d-b2d4-b14d94f7d20c	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112

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	41bf4a72-9288-50a1-e063-6394a90a5e7c	2
199246	glimepiride 2 MG Oral Tablet	SCD	41bf4a72-9288-50a1-e063-6394a90a5e7c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1608-3	67046160803	30 TABLET in 1 BLISTER PACK (67046-1608-3)	30 tablet	2025-10-22	No	No	Current