FDA.reportPublic FDA data

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46708-411-302023-02-01C16284748780-1f386c64a-244a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DEFERASIROX TABLETS safely and effectively. See full prescribing information for DEFERASIROX TABLETS. DEFERASIROX tablets, for oral use Initial U.S. Approval: 2005
46708-411-912023-02-01C16284748780-1f386c64a-244a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DEFERASIROX TABLETS safely and effectively. See full prescribing information for DEFERASIROX TABLETS. DEFERASIROX tablets, for oral use Initial U.S. Approval: 2005
46708-411-302023-01-30C16284748780-1f386c64a-244a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DEFERASIROX TABLETS safely and effectively. See full prescribing information for DEFERASIROX TABLETS. DEFERASIROX tablets, for oral use Initial U.S. Approval: 2005
46708-411-912023-01-30C16284748780-1f386c64a-244a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DEFERASIROX TABLETS safely and effectively. See full prescribing information for DEFERASIROX TABLETS. DEFERASIROX tablets, for oral use Initial U.S. Approval: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-411-30DEFERASIROX30 in 1 BOTTLETABLET, FILM COATED303
46708-411-91DEFERASIROX1000 in 1 BOTTLETABLET, FILM COATED10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-411DEFERASIROX TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 2 package rows20230202_dd9450f4-7c95-4322-8806-9820570f5aa2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1607784deferasirox 180 MG Oral TabletPSNdd9450f4-7c95-4322-8806-9820570f5aa23
1607792deferasirox 360 MG Oral TabletPSNdd9450f4-7c95-4322-8806-9820570f5aa23
1607796deferasirox 90 MG Oral TabletPSNdd9450f4-7c95-4322-8806-9820570f5aa23
1607784deferasirox 180 MG Oral TabletSCDdd9450f4-7c95-4322-8806-9820570f5aa23
1607792deferasirox 360 MG Oral TabletSCDdd9450f4-7c95-4322-8806-9820570f5aa23
1607796deferasirox 90 MG Oral TabletSCDdd9450f4-7c95-4322-8806-9820570f5aa23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-411-304670804113030 TABLET, FILM COATED in 1 BOTTLE (46708-411-30) 2020-06-150000-00-00NoNoCurrent
46708-411-91467080411911000 TABLET, FILM COATED in 1 BOTTLE (46708-411-91) 2020-06-150000-00-00NoNoCurrent