Glimepiride

Product NDC: 43063-698
11-digit product format: 430630698
Labeler code: 43063
Product ID: 43063-698_2b376d88-25a8-b97f-e063-6394a90adfed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA077911
Marketing category: ANDA
Marketing start: 2012-01-01
Substance: GLIMEPIRIDE
Active strength: 2 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	2 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	6KY687524K
Rxcui	199246

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
43063-698-30	Glimepiride	30 in 1 BOTTLE, PLASTIC	TABLET	30		22
43063-698-90	Glimepiride	90 in 1 BOTTLE, PLASTIC	TABLET	90		22
43063-698-93	Glimepiride	180 in 1 BOTTLE, PLASTIC	TABLET	180		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-698-30	EA - Each	43063-698	8948af79-176b-4f21-81c3-8e0fe9ffcd04	1	2019-10-07
43063-698-90	EA - Each	43063-698	03cfd90c-a34c-49d7-b35b-17259805bac3	1	2016-09-02
43063-698-93	EA - Each	43063-698	41624a3c-6367-45c2-9808-93800d3f6312	1	2016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-698	GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	22	Current NDC, Legacy NDC, 3 package rows	20250112_11ae3189-6139-4470-95d5-72abc0f5b0d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199246	glimepiride 2 MG Oral Tablet	PSN	11ae3189-6139-4470-95d5-72abc0f5b0d0	22
199246	glimepiride 2 MG Oral Tablet	SCD	11ae3189-6139-4470-95d5-72abc0f5b0d0	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-698-30	43063069830	30 TABLET in 1 BOTTLE, PLASTIC (43063-698-30)	30 tablet	2019-09-05	0000-00-00	No	No	Current
43063-698-90	43063069890	90 TABLET in 1 BOTTLE, PLASTIC (43063-698-90)	90 tablet	2016-08-01	0000-00-00	No	No	Current
43063-698-93	43063069893	180 TABLET in 1 BOTTLE, PLASTIC (43063-698-93)	180 tablet	2016-08-01	0000-00-00	No	No	Current