Deferasirox

Product NDC
69539-074
11-digit product format
695390074
Labeler code
69539
Product ID
69539-074_da168049-e499-4563-afe8-82ae754ed640
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deferasirox
Dosage form
TABLET
Route
ORAL
Labeler
MSN LABORATORIES PRIVATE LIMITED
Application
ANDA210945
Marketing category
ANDA
Marketing start
2020-06-16
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
Rxcui1607784, 1607792, 1607796

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e1ec29c-8ce7-9963-3c87-cf7d9cd3b139Product name520250624
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
0feb0248-301d-406d-9b41-7d80ddbec8a8Product name420201216

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69539-074-30Deferasirox30 in 1 BOTTLETABLET307
69539-074-99Deferasirox1000 in 1 BOTTLETABLET10007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69539-074DEFERASIROX TABLET [MSN LABORATORIES PRIVATE LIMITED]7Current NDC, Legacy NDC, 2 package rows20210109_0354cbc7-9b32-4513-976a-2ef2da39b6b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1607784deferasirox 180 MG Oral TabletPSN0354cbc7-9b32-4513-976a-2ef2da39b6b37
1607792deferasirox 360 MG Oral TabletPSN0354cbc7-9b32-4513-976a-2ef2da39b6b37
1607796deferasirox 90 MG Oral TabletPSN0354cbc7-9b32-4513-976a-2ef2da39b6b37
1607784deferasirox 180 MG Oral TabletSCD0354cbc7-9b32-4513-976a-2ef2da39b6b37
1607792deferasirox 360 MG Oral TabletSCD0354cbc7-9b32-4513-976a-2ef2da39b6b37
1607796deferasirox 90 MG Oral TabletSCD0354cbc7-9b32-4513-976a-2ef2da39b6b37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69539-074-306953900743030 TABLET in 1 BOTTLE (69539-074-30) 30 tablet2020-06-160000-00-00NoNoCurrent
69539-074-99695390074991000 TABLET in 1 BOTTLE (69539-074-99) 1000 tablet2020-06-160000-00-00NoNoCurrent