GLIMEPIRIDE

Product NDC: 61919-250
Requested package NDC: 61919-250-60
11-digit product format: 619190250
Labeler code: 61919
Product ID: 61919-250_f2030f1c-9993-4b65-e053-2995a90ac5eb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GLIMEPIRIDE
Dosage form: TABLET
Route: ORAL
Labeler: DIRECT RX
Application: ANDA078181
Marketing category: ANDA
Marketing start: 2016-02-04
Marketing end: 0000-00-00
Substance: GLIMEPIRIDE
Active strength: 4 mg/1
Pharmacologic classes: Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag: No
Listing certified through: 2024-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61919-250	61919-250-60	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A078181-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078181-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078181-003	AB	1	`a50c72e98297…`

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
61919-250-04	2025-01-30	C162847	48780-1	2cef2736-5f1e-d83d-e063-dadaa90ab31f	GLIMEPIRIDE
61919-250-30	2025-01-30	C162847	48780-1	2cef2736-5f1e-d83d-e063-dadaa90ab31f	GLIMEPIRIDE
61919-250-60	2025-01-30	C162847	48780-1	2cef2736-5f1e-d83d-e063-dadaa90ab31f	GLIMEPIRIDE
61919-250-82	2025-01-30	C162847	48780-1	2cef2736-5f1e-d83d-e063-dadaa90ab31f	GLIMEPIRIDE
61919-250-90	2025-01-30	C162847	48780-1	2cef2736-5f1e-d83d-e063-dadaa90ab31f	GLIMEPIRIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-250-04	GLIMEPIRIDE	4 in 1 BOTTLE	TABLET	4	3
61919-250-30	GLIMEPIRIDE	30 in 1 BOTTLE	TABLET	30	3
61919-250-60	GLIMEPIRIDE	60 in 1 BOTTLE	TABLET	60	3
61919-250-82	GLIMEPIRIDE	180 in 1 BOTTLE	TABLET	180	3
61919-250-90	GLIMEPIRIDE	90 in 1 BOTTLE	TABLET	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-250-04	EA - Each	61919-250	2601b77b-4655-42b5-8fd3-912022b281af	1	2019-12-10
61919-250-30	EA - Each	61919-250	e266c593-4301-43b8-ad88-0500b79137ad	1	2019-12-10
61919-250-60	EA - Each	61919-250	d940960e-fe9c-4260-8dd0-d8093e591633	1	2019-12-10
61919-250-82	EA - Each	61919-250	2fb0de70-2a6d-4239-a4df-af2c74796c5a	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-250	GLIMEPIRIDE TABLET [DIRECT RX]	3	Legacy NDC, 5 package rows	20230113_2b57dfa7-f2c2-45ca-e054-00144ff8d46c.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	2b57dfa7-f2c2-45ca-e054-00144ff8d46c	3
199247	glimepiride 4 MG Oral Tablet	SCD	2b57dfa7-f2c2-45ca-e054-00144ff8d46c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-250-60	61919025060	60 TABLET in 1 BOTTLE (61919-250-60)	60 tablet	2016-02-04	0000-00-00	No	No	Current