Deferasirox

Product NDC
31722-011
11-digit product format
317220011
Labeler code
31722
Product ID
31722-011_2dda6e62-958f-b0ce-e063-6394a90ab671
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deferasirox
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA214341
Marketing category
ANDA
Marketing start
2021-05-14
Substance
DEFERASIROX
Active strength
90 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
DEFERASIROX90 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
31722-011-30Deferasirox30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-011-30EA - Each31722-0119e63743d-ae31-46c7-9ec4-d7ebfb03e49f12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-011DEFERASIROX (DEFERASIROX) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 1 package rows20250213_65453013-c360-4835-8358-2a278a4a32db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1607784deferasirox 180 MG Oral TabletPSN65453013-c360-4835-8358-2a278a4a32db3
1607792deferasirox 360 MG Oral TabletPSN65453013-c360-4835-8358-2a278a4a32db3
1607796deferasirox 90 MG Oral TabletPSN65453013-c360-4835-8358-2a278a4a32db3
1607784deferasirox 180 MG Oral TabletSCD65453013-c360-4835-8358-2a278a4a32db3
1607792deferasirox 360 MG Oral TabletSCD65453013-c360-4835-8358-2a278a4a32db3
1607796deferasirox 90 MG Oral TabletSCD65453013-c360-4835-8358-2a278a4a32db3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-011-303172200113030 TABLET, FILM COATED in 1 BOTTLE (31722-011-30) 2021-05-140000-00-00NoNoCurrent