Deferasirox

Product NDC
62332-326
11-digit product format
623320326
Labeler code
62332
Product ID
62332-326_d58faf4c-c55c-47fc-928a-f56e8240a85c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deferasirox
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA210060
Marketing category
ANDA
Marketing start
2019-11-21
Substance
DEFERASIROX
Active strength
500 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
DEFERASIROX500 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
62332-326-30Deferasirox30 in 1 BOTTLETABLET, FOR SUSPENSION3017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-326-30EA - Each62332-3263c7e7b45-45a2-4fbf-a496-447e50a18d7e12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-326DEFERASIROX TABLET, FOR SUSPENSION [ALEMBIC PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 1 package rows20230329_1f9f1a69-bf71-4e6a-88b0-90f08c4da79f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597768deferasirox 125 MG Tablet for Oral SuspensionPSN1f9f1a69-bf71-4e6a-88b0-90f08c4da79f17
597770deferasirox 250 MG Tablet for Oral SuspensionPSN1f9f1a69-bf71-4e6a-88b0-90f08c4da79f17
597772deferasirox 500 MG Tablet for Oral SuspensionPSN1f9f1a69-bf71-4e6a-88b0-90f08c4da79f17
597768deferasirox 125 MG Tablet for Oral SuspensionSCD1f9f1a69-bf71-4e6a-88b0-90f08c4da79f17
597770deferasirox 250 MG Tablet for Oral SuspensionSCD1f9f1a69-bf71-4e6a-88b0-90f08c4da79f17
597772deferasirox 500 MG Tablet for Oral SuspensionSCD1f9f1a69-bf71-4e6a-88b0-90f08c4da79f17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-326-306233203263030 TABLET, FOR SUSPENSION in 1 BOTTLE (62332-326-30) 2019-11-210000-00-00NoNoCurrent