deferasirox

Product NDC
70771-1472
11-digit product format
707711472
Labeler code
70771
Product ID
70771-1472_9e909702-4471-4cd1-8e97-56b38fba9aa6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
deferasirox
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA211383
Marketing category
ANDA
Marketing start
2020-06-16
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

Additional Listing Data#

Finished product
Yes
Brand name base
deferasirox
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEFERASIROX180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV8G4MOF2V9
Rxcui1607784, 1607792, 1607796

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
70771-1472-1deferasirox100 in 1 BOTTLETABLET, FILM COATED1006
70771-1472-3deferasirox30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1472DEFERASIROX TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 2 package rows20241130_fcd2ffe2-c8ba-400b-b7f9-e0e4b3510b98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1607784deferasirox 180 MG Oral TabletPSNfcd2ffe2-c8ba-400b-b7f9-e0e4b3510b986
1607792deferasirox 360 MG Oral TabletPSNfcd2ffe2-c8ba-400b-b7f9-e0e4b3510b986
1607796deferasirox 90 MG Oral TabletPSNfcd2ffe2-c8ba-400b-b7f9-e0e4b3510b986
1607784deferasirox 180 MG Oral TabletSCDfcd2ffe2-c8ba-400b-b7f9-e0e4b3510b986
1607792deferasirox 360 MG Oral TabletSCDfcd2ffe2-c8ba-400b-b7f9-e0e4b3510b986
1607796deferasirox 90 MG Oral TabletSCDfcd2ffe2-c8ba-400b-b7f9-e0e4b3510b986

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70771-1472-170771147201100 TABLET, FILM COATED in 1 BOTTLE (70771-1472-1) 2020-06-160000-00-00NoNoCurrent
70771-1472-37077114720330 TABLET, FILM COATED in 1 BOTTLE (70771-1472-3) 2020-06-160000-00-00NoNoCurrent