Deferasirox

Product NDC
0480-7012
11-digit product format
004807012
Labeler code
0480
Product ID
0480-7012_41368299-3cb6-4cee-885e-5c1cc8e4fee6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deferasirox
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA207124
Marketing category
ANDA
Marketing start
2024-11-01
Substance
DEFERASIROX
Active strength
250 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
DEFERASIROX250 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
0480-7012-56Deferasirox30 in 1 BOTTLETABLET, FOR SUSPENSION307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-7012-56EA - Each0480-70127fc6e671-7d42-43d6-99ee-7b5315262b1012024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-7012DEFERASIROX TABLET, FOR SUSPENSION [TEVA PHARMACEUTICALS, INC.]6Current NDC, 1 package rows20241210_e9054806-2721-4736-9aef-81ffb8db75d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597768deferasirox 125 MG Tablet for Oral SuspensionPSNe9054806-2721-4736-9aef-81ffb8db75d17
597770deferasirox 250 MG Tablet for Oral SuspensionPSNe9054806-2721-4736-9aef-81ffb8db75d17
597772deferasirox 500 MG Tablet for Oral SuspensionPSNe9054806-2721-4736-9aef-81ffb8db75d17
597768deferasirox 125 MG Tablet for Oral SuspensionSCDe9054806-2721-4736-9aef-81ffb8db75d17
597770deferasirox 250 MG Tablet for Oral SuspensionSCDe9054806-2721-4736-9aef-81ffb8db75d17
597772deferasirox 500 MG Tablet for Oral SuspensionSCDe9054806-2721-4736-9aef-81ffb8db75d17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0480-7012-560048070125630 TABLET, FOR SUSPENSION in 1 BOTTLE (0480-7012-56) 2024-11-01NoNoCurrent