Glimepiride

Product NDC: 63629-5650
11-digit product format: 636295650
Labeler code: 63629
Product ID: 63629-5650_bf2f2303-19c6-4a93-b9ca-6efc1b445124
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078181
Marketing category: ANDA
Marketing start: 2007-08-23
Marketing end: 0000-00-00
Substance: GLIMEPIRIDE
Active strength: 1 mg/1
Pharmacologic classes: Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-5650		I	Inactivated by FDA	2026-07-31
excluded package	package	63629-5650	63629-5650-1	I	Inactivated by FDA	2026-07-31
excluded package	package	63629-5650	63629-5650-2	I	Inactivated by FDA	2026-07-31
excluded package	package	63629-5650	63629-5650-3	I	Inactivated by FDA	2026-07-31
excluded package	package	63629-5650	63629-5650-4	I	Inactivated by FDA	2026-07-31
excluded package	package	63629-5650	63629-5650-5	I	Inactivated by FDA	2026-07-31

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
63629-5650-1	2025-01-30	C162847	48780-1	2cef2736-6c54-d83d-e063-dadaa90ab31f	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 us Initial U.S. Approval: 1995
63629-5650-2	2025-01-30	C162847	48780-1	2cef2736-6c54-d83d-e063-dadaa90ab31f	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 us Initial U.S. Approval: 1995
63629-5650-3	2025-01-30	C162847	48780-1	2cef2736-6c54-d83d-e063-dadaa90ab31f	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 us Initial U.S. Approval: 1995
63629-5650-4	2025-01-30	C162847	48780-1	2cef2736-6c54-d83d-e063-dadaa90ab31f	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 us Initial U.S. Approval: 1995
63629-5650-5	2025-01-30	C162847	48780-1	2cef2736-6c54-d83d-e063-dadaa90ab31f	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 us Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-5650-1	Glimepiride	30 in 1 BOTTLE	TABLET	30	1016
63629-5650-2	Glimepiride	60 in 1 BOTTLE	TABLET	60	1016
63629-5650-3	Glimepiride	90 in 1 BOTTLE	TABLET	90	1016
63629-5650-4	Glimepiride	100 in 1 BOTTLE	TABLET	100	1016
63629-5650-5	Glimepiride	20 in 1 BOTTLE	TABLET	20	1016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-5650	GLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]	1016	Legacy NDC, 5 package rows	20231129_bf2f2303-19c6-4a93-b9ca-6efc1b445124.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
199245	glimepiride 1 MG Oral Tablet	PSN	bf2f2303-19c6-4a93-b9ca-6efc1b445124	1016
199245	glimepiride 1 MG Oral Tablet	SCD	bf2f2303-19c6-4a93-b9ca-6efc1b445124	1016

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-5650-1	63629565001	30 TABLET in 1 BOTTLE (63629-5650-1)	30 tablet	2015-05-28	0000-00-00	No	No	Current
63629-5650-2	63629565002	60 TABLET in 1 BOTTLE (63629-5650-2)	60 tablet	2015-05-28	0000-00-00	No	No	Current
63629-5650-3	63629565003	90 TABLET in 1 BOTTLE (63629-5650-3)	90 tablet	2015-05-28	0000-00-00	No	No	Current
63629-5650-4	63629565004	100 TABLET in 1 BOTTLE (63629-5650-4)	100 tablet	2015-05-28	0000-00-00	No	No	Current
63629-5650-5	63629565005	20 TABLET in 1 BOTTLE (63629-5650-5)	20 tablet	2015-05-28	0000-00-00	No	No	Current