Ambrisentan

Product NDC
49884-353
11-digit product format
498840353
Labeler code
49884
Product ID
49884-353_3d907352-b0a8-4d87-bb3f-235433818d10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ambrisentan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA209509
Marketing category
ANDA
Marketing start
2019-04-16
Marketing end
2023-01-31
Substance
AMBRISENTAN
Active strength
5 mg/1
Pharmacologic classes
Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-353-11EA - Each49884-3538822078a-67e4-40ab-b87c-00c17fa68b7812019-05-02
49884-353-62EA - Each49884-353a1af3c77-89a4-4190-b986-d937ad565a4912019-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49884-353-114988403531130 TABLET, FILM COATED in 1 BOTTLE (49884-353-11) 2019-04-162023-01-31NoNoCurrent
49884-353-624988403536210 TABLET, FILM COATED in 1 BOTTLE (49884-353-62) 2019-04-162023-01-31NoNoCurrent