APREMILAST

Product NDC
60219-1410
11-digit product format
602191410
Labeler code
60219
Product ID
60219-1410_ee9b2224-736a-4dd1-8e8f-6795bf73300e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
APREMILAST
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA211782
Marketing category
ANDA
Marketing start
2021-07-05
Marketing end
0000-00-00
Substance
APREMILAST
Active strength
30 mg/1
Pharmacologic classes
Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA]
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
NDCEffectiveActionDocumentIndexing SPLRelated label
60219-1410-62025-02-18C16284748780-1f386c649-f4d6-0266-e053-dadaa90a7c1a6b37f813-113f-48f3-904c-7d14401ab13d
60219-1410-62023-01-30C16284748780-1f386c649-f4d6-0266-e053-dadaa90a7c1a6b37f813-113f-48f3-904c-7d14401ab13d

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-1410APREMILAST KIT APREMILAST TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]8Legacy NDC20250223_6b37f813-113f-48f3-904c-7d14401ab13d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60219-1410-66021914100660 TABLET, FILM COATED in 1 BOTTLE (60219-1410-6) 2021-07-050000-00-00NoNoCurrent