FDA.reportPublic FDA data

Deferasirox

Product NDC
43598-854
11-digit product format
435980854
Labeler code
43598
Product ID
43598-854_764cc47a-a6dc-3c11-cf22-c5d2f8db72dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deferasirox
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA209878
Marketing category
ANDA
Marketing start
2019-11-20
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
43598-854-05Deferasirox500 in 1 BOTTLETABLET, FOR SUSPENSION5002
43598-854-30Deferasirox30 in 1 BOTTLETABLET, FOR SUSPENSION302
43598-854-90Deferasirox90 in 1 BOTTLETABLET, FOR SUSPENSION902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-854-30EA - Each43598-85473bfe35a-36be-43c2-a10c-16921cff62fc12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-854DEFERASIROX TABLET, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]2Current NDC, Legacy NDC, 3 package rows20210701_e365e748-4b61-94f2-fb7a-f81919eaccaa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597768deferasirox 125 MG Tablet for Oral SuspensionPSNe365e748-4b61-94f2-fb7a-f81919eaccaa2
597770deferasirox 250 MG Tablet for Oral SuspensionPSNe365e748-4b61-94f2-fb7a-f81919eaccaa2
597772deferasirox 500 MG Tablet for Oral SuspensionPSNe365e748-4b61-94f2-fb7a-f81919eaccaa2
597768deferasirox 125 MG Tablet for Oral SuspensionSCDe365e748-4b61-94f2-fb7a-f81919eaccaa2
597770deferasirox 250 MG Tablet for Oral SuspensionSCDe365e748-4b61-94f2-fb7a-f81919eaccaa2
597772deferasirox 500 MG Tablet for Oral SuspensionSCDe365e748-4b61-94f2-fb7a-f81919eaccaa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-854-0543598085405500 TABLET, FOR SUSPENSION in 1 BOTTLE (43598-854-05) 2019-11-200000-00-00NoNoCurrent
43598-854-304359808543030 TABLET, FOR SUSPENSION in 1 BOTTLE (43598-854-30) 2019-11-200000-00-00NoNoCurrent
43598-854-904359808549090 TABLET, FOR SUSPENSION in 1 BOTTLE (43598-854-90) 2019-11-200000-00-00NoNoCurrent