Glimepiride

Product NDC: 71610-236
11-digit product format: 716100236
Labeler code: 71610
Product ID: 71610-236_51de9fdb-99a3-41a6-a7ef-ec6c5f819088
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA077911
Marketing category: ANDA
Marketing start: 2009-08-17
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

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 Identifiers#

Field, Values table
Field	Values
Unii	6KY687524K
Rxcui	199247

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
71610-236-60	Glimepiride	90 in 1 BOTTLE	TABLET	90		1
71610-236-80	Glimepiride	180 in 1 BOTTLE	TABLET	180		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-236-60	EA - Each	71610-236	750213c3-cf49-425c-b790-80f9dbeae0fb	1	2019-03-12
71610-236-80	EA - Each	71610-236	1d1ca9d9-131d-4833-9469-740615192ea5	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-236	GLIMEPIRIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Current NDC, Legacy NDC, 2 package rows	20190215_00b9e312-921e-41e6-ad27-0a6ce87f8298.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199247	glimepiride 4 MG Oral Tablet	PSN	00b9e312-921e-41e6-ad27-0a6ce87f8298	1
199247	glimepiride 4 MG Oral Tablet	SCD	00b9e312-921e-41e6-ad27-0a6ce87f8298	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-236-60	71610023660	90 TABLET in 1 BOTTLE (71610-236-60)	90 tablet	2019-02-13	0000-00-00	No	No	Current
71610-236-80	71610023680	180 TABLET in 1 BOTTLE (71610-236-80)	180 tablet	2019-02-13	0000-00-00	No	No	Current