FDA.reportPublic FDA data

Deferasirox

Product NDC
69539-021
11-digit product format
695390021
Labeler code
69539
Product ID
69539-021_4b237031-5375-4a5a-8a5d-21527f6fc7da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deferasirox
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Labeler
MSN LABORATORIES PRIVATE LIMITED
Application
ANDA209878
Marketing category
ANDA
Marketing start
2019-11-20
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
69539-021-06Deferasirox10 in 1 CARTONTABLET, FOR SUSPENSION1013
69539-021-11Deferasirox10 in 1 BLISTER PACKTABLET, FOR SUSPENSION1013
69539-021-30Deferasirox30 in 1 BOTTLETABLET, FOR SUSPENSION3013
69539-021-90Deferasirox90 in 1 BOTTLETABLET, FOR SUSPENSION9013
69539-021-99Deferasirox1000 in 1 BOTTLETABLET, FOR SUSPENSION100013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69539-021DEFERASIROX TABLET, FOR SUSPENSION [MSN LABORATORIES PRIVATE LIMITED]13Current NDC, Legacy NDC, 5 package rows20210113_e0726c9c-cee8-4fc1-abd1-68ad0db030dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597768deferasirox 125 MG Tablet for Oral SuspensionPSNe0726c9c-cee8-4fc1-abd1-68ad0db030dd13
597770deferasirox 250 MG Tablet for Oral SuspensionPSNe0726c9c-cee8-4fc1-abd1-68ad0db030dd13
597772deferasirox 500 MG Tablet for Oral SuspensionPSNe0726c9c-cee8-4fc1-abd1-68ad0db030dd13
597768deferasirox 125 MG Tablet for Oral SuspensionSCDe0726c9c-cee8-4fc1-abd1-68ad0db030dd13
597770deferasirox 250 MG Tablet for Oral SuspensionSCDe0726c9c-cee8-4fc1-abd1-68ad0db030dd13
597772deferasirox 500 MG Tablet for Oral SuspensionSCDe0726c9c-cee8-4fc1-abd1-68ad0db030dd13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69539-021-066953900210610 BLISTER PACK in 1 CARTON (69539-021-06) / 10 TABLET, FOR SUSPENSION in 1 BLISTER PACK (69539-021-11) 10 blister pack2020-02-120000-00-00NoNoCurrent
69539-021-116953900211110 in 1 BLISTER PACKHistorical
69539-021-306953900213030 TABLET, FOR SUSPENSION in 1 BOTTLE (69539-021-30) 2019-11-200000-00-00NoNoCurrent
69539-021-906953900219090 TABLET, FOR SUSPENSION in 1 BOTTLE (69539-021-90) 2019-11-200000-00-00NoNoCurrent
69539-021-99695390021991000 TABLET, FOR SUSPENSION in 1 BOTTLE (69539-021-99) 2019-11-200000-00-00NoNoCurrent