FDA.reportPublic FDA data

Deferasirox

Product NDC
46708-324
11-digit product format
467080324
Labeler code
46708
Product ID
46708-324_3b7b2b3c-507c-4ea9-a45d-f5e38f9e1b80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deferasirox
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA210060
Marketing category
ANDA
Marketing start
2019-11-21
Substance
DEFERASIROX
Active strength
125 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
DEFERASIROX125 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46708-324-302023-02-01C16284748780-1f386c649-e6ee-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DEFERASIROX TABLETS FOR ORAL SUSPENSION safely and effectively. See full prescribing information for DEFERASIROX TABLETS FOR ORAL SUSPENSION. DEFERASIROX tablets for oral suspension Initial U.S. Approval: 2005
46708-324-302023-01-30C16284748780-1f386c649-e6ee-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DEFERASIROX TABLETS FOR ORAL SUSPENSION safely and effectively. See full prescribing information for DEFERASIROX TABLETS FOR ORAL SUSPENSION. DEFERASIROX tablets for oral suspension Initial U.S. Approval: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-324-30Deferasirox30 in 1 BOTTLETABLET, FOR SUSPENSION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-324DEFERASIROX TABLET, FOR SUSPENSION [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 1 package rows20230202_8c8b84f3-6887-4485-b5e0-03f254b88a15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597768deferasirox 125 MG Tablet for Oral SuspensionPSN8c8b84f3-6887-4485-b5e0-03f254b88a152
597770deferasirox 250 MG Tablet for Oral SuspensionPSN8c8b84f3-6887-4485-b5e0-03f254b88a152
597772deferasirox 500 MG Tablet for Oral SuspensionPSN8c8b84f3-6887-4485-b5e0-03f254b88a152
597768deferasirox 125 MG Tablet for Oral SuspensionSCD8c8b84f3-6887-4485-b5e0-03f254b88a152
597770deferasirox 250 MG Tablet for Oral SuspensionSCD8c8b84f3-6887-4485-b5e0-03f254b88a152
597772deferasirox 500 MG Tablet for Oral SuspensionSCD8c8b84f3-6887-4485-b5e0-03f254b88a152

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-324-304670803243030 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-324-30) 2019-11-210000-00-00NoNoCurrent