FDA.reportPublic FDA data

deferasirox

Product NDC
68462-494
11-digit product format
684620494
Labeler code
68462
Product ID
68462-494_e2349a09-1e53-462c-b185-225ca0a400a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
deferasirox
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA209433
Marketing category
ANDA
Marketing start
2020-01-06
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-494-30deferasirox30 in 1 BOTTLETABLET, FOR SUSPENSION305
68462-494-90deferasirox90 in 1 BOTTLETABLET, FOR SUSPENSION905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-494-30EA - Each68462-494fa45fc9c-2f87-4426-9018-2963aaabb6b012020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-494DEFERASIROX TABLET, FOR SUSPENSION [GLENMARK PHARMACEUTICALS INC., USA]5Current NDC, Legacy NDC, 2 package rows20241127_59f1d3fb-5bdb-4261-8557-9a4bde8b3c1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597768deferasirox 125 MG Tablet for Oral SuspensionPSN59f1d3fb-5bdb-4261-8557-9a4bde8b3c1c5
597770deferasirox 250 MG Tablet for Oral SuspensionPSN59f1d3fb-5bdb-4261-8557-9a4bde8b3c1c5
597772deferasirox 500 MG Tablet for Oral SuspensionPSN59f1d3fb-5bdb-4261-8557-9a4bde8b3c1c5
597768deferasirox 125 MG Tablet for Oral SuspensionSCD59f1d3fb-5bdb-4261-8557-9a4bde8b3c1c5
597770deferasirox 250 MG Tablet for Oral SuspensionSCD59f1d3fb-5bdb-4261-8557-9a4bde8b3c1c5
597772deferasirox 500 MG Tablet for Oral SuspensionSCD59f1d3fb-5bdb-4261-8557-9a4bde8b3c1c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-494-306846204943030 TABLET, FOR SUSPENSION in 1 BOTTLE (68462-494-30) 2020-01-060000-00-00NoNoCurrent
68462-494-906846204949090 TABLET, FOR SUSPENSION in 1 BOTTLE (68462-494-90) 2020-01-060000-00-00NoNoCurrent