Glimepiride

Product NDC: 16571-775
11-digit product format: 165710775
Labeler code: 16571
Product ID: 16571-775_f06a97e3-4349-4df3-87de-4479c1ed69bc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA202759
Marketing category: ANDA
Marketing start: 2012-06-29
Substance: GLIMEPIRIDE
Active strength: 4 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
A202759-001	GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29
A202759-002	GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29
A202759-003	GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202759-001	AB
A202759-002	AB
A202759-003	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	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`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	A202759-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202759-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202759-003	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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glimepiride	GLIMEPIRIDE	St. Mary's Medical Park Pharmacy	fc9d8495-184c-3af1-e053-6394a90a5e29	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Preferred Pharmaceuticals Inc.	744a5cca-7863-491a-b43a-1b649791702c	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	248c3cb3-4501-4b85-bd1d-0624b6afda2c	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	90d675cb-6def-49a3-b8b4-229f19d6b617	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Aurobindo Pharma Limited	28eefc95-d92e-4555-b6c5-2933860b0610	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	1450f455-a14a-4f9b-b3aa-dae49ea0c186	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	dbed06f9-7758-4c96-9af0-1ed6103db7df	2026-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	e12ab052-e3d6-4246-b727-f1e3f9057f09	2026-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Rising Pharma Holdings, Inc.	48ada723-8144-497d-afd6-a8c52a1dd3ff	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759 ndc (product): 16571-775
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	b6ce0eea-149d-4aed-a615-0b1c8f3f6a8e	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Northwind Health Company, LLC	10a36c79-1b24-46b7-e063-6294a90a8dca	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	489dc098-0ac7-4f8e-b258-326229539c7c	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	be7175ae-ba53-45b8-9554-e4f4ebf56883	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Direct_Rx	fd26934e-daea-f47b-e053-6394a90a4bc6	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	a11680ba-2750-43ab-a1b1-a52ebe3e139f	2023-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	e8da2484-43a7-4dcb-84d5-d84596feb9f6	2023-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	8f687fa6-54eb-4556-8ea6-aafec49a87d1	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759

Additional Listing Data#

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

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
48ada723-8144-497d-afd6-a8c52a1dd3ff	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
16571-775-01	Glimepiride	100 in 1 BOTTLE	TABLET	100		4
16571-775-50	Glimepiride	500 in 1 BOTTLE	TABLET	500		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-775-01	EA - Each	16571-775	001dae49-5b2e-48ba-9391-2ec3dbdee476	1	2022-03-09
16571-775-50	EA - Each	16571-775	fec7bd9c-38f6-459c-bff1-9757cc9a3c90	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-775	GLIMEPIRIDE TABLET [RISING PHARMA HOLDINGS, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20231101_48ada723-8144-497d-afd6-a8c52a1dd3ff.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	90d675cb-6def-49a3-b8b4-229f19d6b617	105
199247	glimepiride 4 MG Oral Tablet	SCD	90d675cb-6def-49a3-b8b4-229f19d6b617	105
199247	glimepiride 4 MG Oral Tablet	PSN	b6ce0eea-149d-4aed-a615-0b1c8f3f6a8e	9
199247	glimepiride 4 MG Oral Tablet	SCD	b6ce0eea-149d-4aed-a615-0b1c8f3f6a8e	9
199245	glimepiride 1 MG Oral Tablet	PSN	48ada723-8144-497d-afd6-a8c52a1dd3ff	4
199246	glimepiride 2 MG Oral Tablet	PSN	48ada723-8144-497d-afd6-a8c52a1dd3ff	4
199247	glimepiride 4 MG Oral Tablet	PSN	48ada723-8144-497d-afd6-a8c52a1dd3ff	4
199247	glimepiride 4 MG Oral Tablet	PSN	744a5cca-7863-491a-b43a-1b649791702c	4
199245	glimepiride 1 MG Oral Tablet	SCD	48ada723-8144-497d-afd6-a8c52a1dd3ff	4
199246	glimepiride 2 MG Oral Tablet	SCD	48ada723-8144-497d-afd6-a8c52a1dd3ff	4
199247	glimepiride 4 MG Oral Tablet	SCD	48ada723-8144-497d-afd6-a8c52a1dd3ff	4
199247	glimepiride 4 MG Oral Tablet	SCD	744a5cca-7863-491a-b43a-1b649791702c	4
199247	glimepiride 4 MG Oral Tablet	PSN	a11680ba-2750-43ab-a1b1-a52ebe3e139f	3
199247	glimepiride 4 MG Oral Tablet	SCD	a11680ba-2750-43ab-a1b1-a52ebe3e139f	3
199247	glimepiride 4 MG Oral Tablet	PSN	fc9d8495-184c-3af1-e053-6394a90a5e29	1
199247	glimepiride 4 MG Oral Tablet	PSN	8f687fa6-54eb-4556-8ea6-aafec49a87d1	1
199247	glimepiride 4 MG Oral Tablet	SCD	8f687fa6-54eb-4556-8ea6-aafec49a87d1	1
199247	glimepiride 4 MG Oral Tablet	SCD	fc9d8495-184c-3af1-e053-6394a90a5e29	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16571-775-01	16571077501	100 TABLET in 1 BOTTLE (16571-775-01)	100 tablet	2012-06-29	0000-00-00	No	No	Current
16571-775-50	16571077550	500 TABLET in 1 BOTTLE (16571-775-50)	500 tablet	2012-06-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glimepiride	St. Mary's Medical Park Pharmacy	2026-06-22	HUMAN PRESCRIPTION DRUG LABEL	2
Glimepiride	Preferred Pharmaceuticals Inc.	2026-05-06	HUMAN PRESCRIPTION DRUG LABEL	4
Glimepiride	Bryant Ranch Prepack	2026-04-13	HUMAN PRESCRIPTION DRUG LABEL	105
Glimepiride	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2026-01-19	Human Prescription Drug Label	4
Glimepiride	A-S Medication Solutions	2025-12-30	Human Prescription Drug Label	9
Glimepiride	REMEDYREPACK INC.	2024-12-02	HUMAN PRESCRIPTION DRUG LABEL	5
Glimepiride	A-S Medication Solutions	2023-09-06	Human Prescription Drug Label	3
Glimepiride	Proficient Rx LP	2023-03-01	HUMAN PRESCRIPTION DRUG LABEL	1