Ambrisentan

Product NDC
49884-354
11-digit product format
498840354
Labeler code
49884
Product ID
49884-354_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
2022-12-31
Substance
AMBRISENTAN
Active strength
10 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
49884-354-11EA - Each49884-354f8848f45-396d-42d9-b744-3979608938da12019-05-02
49884-354-62EA - Each49884-35416ee479d-7a8c-44df-b639-5cd80113dc6412019-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49884-354-114988403541130 TABLET, FILM COATED in 1 BOTTLE (49884-354-11) 2019-04-162022-12-31NoNoCurrent
49884-354-624988403546210 TABLET, FILM COATED in 1 BOTTLE (49884-354-62) 2019-04-162022-12-31NoNoCurrent