DEFERASIROX

Product NDC
31722-030
11-digit product format
317220030
Labeler code
31722
Product ID
31722-030_17f07dc1-8041-d263-e063-6394a90ae223
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEFERASIROX
Dosage form
GRANULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA216229
Marketing category
ANDA
Marketing start
2022-09-22
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
Rxcui1923822, 1923826, 1923828

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
31722-030-32DEFERASIROX30 in 1 CARTONGRANULE304
31722-030-32DEFERASIROX1 in 1 PACKETGRANULE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-030DEFERASIROX (DEFERASIROX) GRANULE [CAMBER PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20240509_eded6687-ba78-4117-a316-eec56d46a08a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923828deferasirox 180 MG Oral GranulesPSNeded6687-ba78-4117-a316-eec56d46a08a4
1923826deferasirox 360 MG Oral GranulesPSNeded6687-ba78-4117-a316-eec56d46a08a4
1923822deferasirox 90 MG Oral GranulesPSNeded6687-ba78-4117-a316-eec56d46a08a4
1923828deferasirox 180 MG Oral GranulesSCDeded6687-ba78-4117-a316-eec56d46a08a4
1923826deferasirox 360 MG Oral GranulesSCDeded6687-ba78-4117-a316-eec56d46a08a4
1923822deferasirox 90 MG Oral GranulesSCDeded6687-ba78-4117-a316-eec56d46a08a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-030-313172200303130 PACKET in 1 CARTON (31722-030-31) > 1 GRANULE in 1 PACKET30 packet2022-09-220000-00-00NoNoCurrent
31722-030-323172200303230 PACKET in 1 CARTON (31722-030-32) / 1 GRANULE in 1 PACKET30 packet2022-09-22NoNoCurrent