Glimepiride

Product NDC: 71921-216
Requested package NDC: 71921-216-50
11-digit product format: 719210216
Labeler code: 71921
Product ID: 71921-216_52fcdeaf-e64f-48bd-b90d-e7502b104ae1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: Florida Pharmaceutical Products, LLC
Application: ANDA202112
Marketing category: ANDA
Marketing start: 2023-07-31
Substance: GLIMEPIRIDE
Active strength: 4 mg/1
Pharmacologic classes: Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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.

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	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`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	A202112-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202112-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202112-003	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 · 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
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 ndc (package): 71921-216-50 ndc (product): 71921-216 ndc11 (package): 71921021650
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

Additional Listing Data#

Finished product: Yes
Brand name base: Glimepiride
Listing expiration: 2026-12-31

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
8ff0de99-272e-4e68-9caf-69f3f146ac29	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
71921-216-01	Glimepiride	100 in 1 BOTTLE	TABLET	100		2
71921-216-50	Glimepiride	500 in 1 BOTTLE	TABLET	500		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71921-216-01	EA - Each	71921-216	7bab6017-3d7c-4978-b56b-ab33df162803	1	2023-09-05
71921-216-50	EA - Each	71921-216	daaf7e16-1802-43e2-bb97-5ce03c24d01e	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71921-216	GLIMEPIRIDE TABLET [FLORIDA PHARMACEUTICAL PRODUCTS, LLC]	2	Current NDC, 2 package rows	20241022_8ff0de99-272e-4e68-9caf-69f3f146ac29.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	79ee7533-f75d-4c49-b396-b339654f5c44	3
199247	glimepiride 4 MG Oral Tablet	PSN	c994796e-dd3d-4f40-a8f2-d317f55e34d5	3
199247	glimepiride 4 MG Oral Tablet	PSN	0c25c987-856f-448d-903a-e2c94049b0a7	3
199247	glimepiride 4 MG Oral Tablet	SCD	0c25c987-856f-448d-903a-e2c94049b0a7	3
199247	glimepiride 4 MG Oral Tablet	SCD	79ee7533-f75d-4c49-b396-b339654f5c44	3
199247	glimepiride 4 MG Oral Tablet	SCD	c994796e-dd3d-4f40-a8f2-d317f55e34d5	3
199245	glimepiride 1 MG Oral Tablet	PSN	8ff0de99-272e-4e68-9caf-69f3f146ac29	2
199246	glimepiride 2 MG Oral Tablet	PSN	8ff0de99-272e-4e68-9caf-69f3f146ac29	2
199247	glimepiride 4 MG Oral Tablet	PSN	8ff0de99-272e-4e68-9caf-69f3f146ac29	2
199245	glimepiride 1 MG Oral Tablet	SCD	8ff0de99-272e-4e68-9caf-69f3f146ac29	2
199246	glimepiride 2 MG Oral Tablet	SCD	8ff0de99-272e-4e68-9caf-69f3f146ac29	2
199247	glimepiride 4 MG Oral Tablet	SCD	8ff0de99-272e-4e68-9caf-69f3f146ac29	2
199247	glimepiride 4 MG Oral Tablet	PSN	230949fd-563e-8dbf-e063-6394a90ab9b6	1
199247	glimepiride 4 MG Oral Tablet	PSN	35ba31ef-2b90-61c6-e063-6394a90a59ee	1
199247	glimepiride 4 MG Oral Tablet	PSN	0b12d4ab-fa0c-44d5-888c-265dbb661561	1
199247	glimepiride 4 MG Oral Tablet	SCD	230949fd-563e-8dbf-e063-6394a90ab9b6	1
199247	glimepiride 4 MG Oral Tablet	SCD	35ba31ef-2b90-61c6-e063-6394a90a59ee	1
199247	glimepiride 4 MG Oral Tablet	SCD	0b12d4ab-fa0c-44d5-888c-265dbb661561	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71921-216-50	71921021650	500 TABLET in 1 BOTTLE (71921-216-50)	500 tablet	2023-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glimepiride	REMEDYREPACK INC.	2025-11-06	HUMAN PRESCRIPTION DRUG LABEL	3
Glimepiride	ST. MARY'S MEDICAL PARK PHARMACY	2025-05-22	HUMAN PRESCRIPTION DRUG LABEL	1
Glimepiride	A-S Medication Solutions	2024-10-25	Human Prescription Drug Label	3
Glimepiride	A-S Medication Solutions	2024-10-25	Human Prescription Drug Label	3
Glimepiride	Florida Pharmaceutical Products, LLC \| INDOCO REMEDIES LIMITED	2024-10-08	Human Prescription Drug Label	2
Glimepiride	Direct_rx	2024-09-26	HUMAN PRESCRIPTION DRUG LABEL	1
Glimepiride	Bryant Ranch Prepack	2024-06-11	HUMAN PRESCRIPTION DRUG LABEL	1
Glimepiride	REMEDYREPACK INC.	2024-04-10	HUMAN PRESCRIPTION DRUG LABEL	2