DEFERASIROX

Product NDC
46708-411
11-digit product format
467080411
Labeler code
46708
Product ID
46708-411_d58c204e-f996-4969-85c7-3fbe078bf6a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEFERASIROX
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA211824
Marketing category
ANDA
Marketing start
2020-06-15
Substance
DEFERASIROX
Active strength
180 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
V8G4MOF2V9DEFERASIROX201530-41-8DEFERASIROX

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
46708-411-304670804113030 TABLET, FILM COATED in 1 BOTTLE (46708-411-30) 2020-06-15NoNoHistorical
46708-411-91467080411911000 TABLET, FILM COATED in 1 BOTTLE (46708-411-91) 2020-06-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DEFERASIROXAlembic Pharmaceuticals Limited2023-01-30Human Prescription Drug Label3