FDA.reportPublic FDA data

Deferasirox

Product NDC
72205-391
11-digit product format
722050391
Labeler code
72205
Product ID
72205-391_a03c7657-fdca-4acb-ad82-c24680e90eae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deferasirox
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA209878
Marketing category
ANDA
Marketing start
2019-11-20
Substance
DEFERASIROX
Active strength
500 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Deferasirox
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEFERASIROX500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV8G4MOF2V9
Rxcui597768, 597770, 597772

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e1ec29c-8ce7-9963-3c87-cf7d9cd3b139Product name520250624
0feb0248-301d-406d-9b41-7d80ddbec8a8Product name420201216

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-391-01Deferasirox30 in 1 BOTTLETABLET, FOR SUSPENSION301
72205-391-02Deferasirox90 in 1 BOTTLETABLET, FOR SUSPENSION901
72205-391-03Deferasirox500 in 1 BOTTLETABLET, FOR SUSPENSION5001
72205-391-05Deferasirox10 in 1 BLISTER PACKTABLET, FOR SUSPENSION101
72205-391-05Deferasirox10 in 1 CARTONTABLET, FOR SUSPENSION101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597768deferasirox 125 MG Tablet for Oral SuspensionPSNa03c7657-fdca-4acb-ad82-c24680e90eae1
597770deferasirox 250 MG Tablet for Oral SuspensionPSNa03c7657-fdca-4acb-ad82-c24680e90eae1
597772deferasirox 500 MG Tablet for Oral SuspensionPSNa03c7657-fdca-4acb-ad82-c24680e90eae1
597768deferasirox 125 MG Tablet for Oral SuspensionSCDa03c7657-fdca-4acb-ad82-c24680e90eae1
597770deferasirox 250 MG Tablet for Oral SuspensionSCDa03c7657-fdca-4acb-ad82-c24680e90eae1
597772deferasirox 500 MG Tablet for Oral SuspensionSCDa03c7657-fdca-4acb-ad82-c24680e90eae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-391-017220503910130 TABLET, FOR SUSPENSION in 1 BOTTLE (72205-391-01) 2026-01-29NoNoHistorical
72205-391-027220503910290 TABLET, FOR SUSPENSION in 1 BOTTLE (72205-391-02) 2026-01-29NoNoHistorical
72205-391-0372205039103500 TABLET, FOR SUSPENSION in 1 BOTTLE (72205-391-03) 2026-01-29NoNoHistorical
72205-391-057220503910510 BLISTER PACK in 1 CARTON (72205-391-05) / 10 TABLET, FOR SUSPENSION in 1 BLISTER PACK10 blister pack2026-01-29NoNoHistorical