Deferasirox

Product NDC
67877-553
11-digit product format
678770553
Labeler code
67877
Product ID
67877-553_5e8c386f-5879-4f68-bc6f-38041072f5ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deferasirox
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA210555
Marketing category
ANDA
Marketing start
2020-07-04
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
67877-553-306787705533030 TABLET, FILM COATED in 1 BOTTLE (67877-553-30) 2020-07-04NoNoHistorical
67877-553-906787705539090 TABLET, FILM COATED in 1 BOTTLE (67877-553-90) 2020-07-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DeferasiroxAscend Laboratories, LLC | Alkem Laboratories Limited2025-06-04Human Prescription Drug Label13