DEFERASIROX

Product NDC
59651-449
11-digit product format
596510449
Labeler code
59651
Product ID
59651-449_c220484e-1e6a-4a0c-a221-60223f3bc24c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEFERASIROX
Dosage form
GRANULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA215137
Marketing category
ANDA
Marketing start
2025-09-08
Substance
DEFERASIROX
Active strength
360 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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-449-305965104493030 PACKET in 1 CARTON (59651-449-30) / 1 GRANULE in 1 PACKET (59651-449-54) 30 packet2025-09-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DEFERASIROX - Aurobindo Pharma Limited | APL HEALTHCARE LIMITEDAurobindo Pharma Limited | APL HEALTHCARE LIMITED2025-09-09Human Prescription Drug Label1