Deferasirox

Product NDC
0591-3853
11-digit product format
005913853
Labeler code
0591
Product ID
0591-3853_dc305bb9-31ee-4cee-8f19-04b0593f4bf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deferasirox
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA208697
Marketing category
ANDA
Marketing start
2019-12-17
Marketing end
0000-00-00
Substance
DEFERASIROX
Active strength
180 mg/1
Pharmacologic classes
Iron Chelating Activity [MoA],Iron Chelator [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-3853-300059138533030 TABLET, FILM COATED in 1 BOTTLE (0591-3853-30) 2019-12-170000-00-00NoNoCurrent