FDA.reportPublic FDA data

Deferasirox

Product NDC
43598-851
11-digit product format
435980851
Labeler code
43598
Product ID
43598-851_95a20658-492c-6693-491b-f651f3a2f25f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deferasirox
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA210945
Marketing category
ANDA
Marketing start
2019-11-20
Substance
DEFERASIROX
Active strength
360 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
DEFERASIROX360 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
0feb0248-301d-406d-9b41-7d80ddbec8a8Product name420201216

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-851-10Deferasirox1000 in 1 BOTTLETABLET10005
43598-851-30Deferasirox30 in 1 BOTTLETABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-851-30EA - Each43598-8514568ad9b-704c-4cf9-b3ab-74b834bb6ecd12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-851DEFERASIROX TABLET [DR. REDDY'S LABORATORIES INC]5Current NDC, Legacy NDC, 2 package rows20241204_350dfc39-d03d-e221-22e9-3880728c955c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1607784deferasirox 180 MG Oral TabletPSN350dfc39-d03d-e221-22e9-3880728c955c5
1607792deferasirox 360 MG Oral TabletPSN350dfc39-d03d-e221-22e9-3880728c955c5
1607796deferasirox 90 MG Oral TabletPSN350dfc39-d03d-e221-22e9-3880728c955c5
1607784deferasirox 180 MG Oral TabletSCD350dfc39-d03d-e221-22e9-3880728c955c5
1607792deferasirox 360 MG Oral TabletSCD350dfc39-d03d-e221-22e9-3880728c955c5
1607796deferasirox 90 MG Oral TabletSCD350dfc39-d03d-e221-22e9-3880728c955c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-851-10435980851101000 TABLET in 1 BOTTLE (43598-851-10) 1000 tablet2019-11-200000-00-00NoNoCurrent
43598-851-304359808513030 TABLET in 1 BOTTLE (43598-851-30) 30 tablet2019-11-200000-00-00NoNoCurrent