Glimepiride

Product NDC: 70934-323
11-digit product format: 709340323
Labeler code: 70934
Product ID: 70934-323_b7b1907c-9120-8dcb-e053-2995a90a57eb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application: ANDA078181
Marketing category: ANDA
Marketing start: 2019-03-20
Marketing end: 0000-00-00
Substance: GLIMEPIRIDE
Active strength: 4 mg/1
Pharmacologic classes: Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70934-323		I	Inactivated by FDA	2026-08-03
excluded package	package	70934-323	70934-323-30	I	Inactivated by FDA	2026-08-03
excluded package	package	70934-323	70934-323-90	I	Inactivated by FDA	2026-08-03

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
A078181-001	GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23
A078181-002	GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23
A078181-003	GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078181-001	AB
A078181-002	AB
A078181-003	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	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`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	A078181-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078181-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078181-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078181-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078181-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078181-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078181-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078181-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078181-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078181-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078181-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078181-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078181-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078181-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078181-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078181-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078181-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078181-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078181-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078181-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078181-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078181-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078181-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078181-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078181-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078181-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078181-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078181-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078181-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078181-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078181-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078181-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078181-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078181-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078181-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078181-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078181-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078181-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078181-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078181-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	9e863f84-d6f2-4d61-8250-774569e84353	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	58c4261e-e98f-4280-9562-2800956dff14	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	1b3c7d74-f80b-4fb1-8dca-66880af5d3fc	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	Northwind Health Company, LLC	3e81a39a-30bb-4d6d-82e1-17d7134365be	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	Northwind Health Company, LLC	f2f2d6da-eb40-4290-e053-2a95a90a6ca0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	Accord Healthcare Inc	9b74fbac-9e04-4927-9981-1e3dace89c6d	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	beb0cefb-807b-4cc3-ada2-7a8ed4aa8f2b	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	5a5747ea-cded-49ed-8807-dd3e2a1159e0	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	68cb4fcd-5bc3-4f53-9085-86df6a4246d6	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70934-323-30	2023-01-30	C162847	48780-1	f386c64a-1633-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use GLIMEPIRIDE TABLETS safely and effectively. See full prescribing information for GLIMEPIRIDE TABLETS. GLIMEPIRIDE tablets for oral use Initial U.S. Approval: 1995
70934-323-90	2023-01-30	C162847	48780-1	f386c64a-1633-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use GLIMEPIRIDE TABLETS safely and effectively. See full prescribing information for GLIMEPIRIDE TABLETS. GLIMEPIRIDE tablets for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70934-323-30	Glimepiride	30 in 1 BOTTLE, PLASTIC	TABLET	30		2
70934-323-90	Glimepiride	90 in 1 BOTTLE, PLASTIC	TABLET	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70934-323-30	EA - Each	70934-323	cf7750c9-21d0-4a9a-940a-5a77e40386f9	1	2022-12-07
70934-323-90	EA - Each	70934-323	e7748530-45f3-48a2-ad60-6913115870d9	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70934-323	GLIMEPIRIDE TABLET [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]	2	Legacy NDC, 2 package rows	20201231_8aaa0f8d-754f-059a-e053-2995a90a0e7f.zip

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	8aaa0f8d-754f-059a-e053-2995a90a0e7f	2
199247	glimepiride 4 MG Oral Tablet	SCD	8aaa0f8d-754f-059a-e053-2995a90a0e7f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70934-323-30	70934032330	30 TABLET in 1 BOTTLE, PLASTIC (70934-323-30)	30 tablet	2019-03-20	0000-00-00	No	No	Current
70934-323-90	70934032390	90 TABLET in 1 BOTTLE, PLASTIC (70934-323-90)	90 tablet	2019-06-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glimepiride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-12-30	HUMAN PRESCRIPTION DRUG LABEL	2