APREMILAST

Product NDC: 60219-1744
11-digit product format: 602191744
Labeler code: 60219
Product ID: 60219-1744_ee9b2224-736a-4dd1-8e8f-6795bf73300e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: APREMILAST
Dosage form: KIT
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA211782
Marketing category: ANDA
Marketing start: 2021-07-05
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60219-1744-7	2025-02-18	C162847	48780-1	f386c649-f4d6-0266-e053-dadaa90a7c1a	6b37f813-113f-48f3-904c-7d14401ab13d
60219-1744-7	2023-01-30	C162847	48780-1	f386c649-f4d6-0266-e053-dadaa90a7c1a	6b37f813-113f-48f3-904c-7d14401ab13d

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60219-1744	APREMILAST KIT APREMILAST TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]	8	Legacy NDC	20250223_6b37f813-113f-48f3-904c-7d14401ab13d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60219-1744-7	60219174407	1 KIT in 1 KIT (60219-1744-7) * 19 TABLET, FILM COATED in 1 BLISTER PACK * 4 TABLET, FILM COATED in 1 BLISTER PACK * 4 TABLET, FILM COATED in 1 BLISTER PACK	1 kit	2021-07-05	0000-00-00	No	No	Current