FDA.reportPublic FDA data

deferasirox

Product NDC
62756-568
11-digit product format
627560568
Labeler code
62756
Product ID
62756-568_88009dbf-bf02-432b-95d4-27a6934590b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
deferasirox
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA209782
Marketing category
ANDA
Marketing start
2019-12-02
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
62756-568-83deferasirox30 in 1 BOTTLETABLET, FOR SUSPENSION3011
62756-568-86deferasirox60 in 1 BOTTLETABLET, FOR SUSPENSION6011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-568-83EA - Each62756-568fe9c9759-52b6-42ad-8ece-63ab5df558c612020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-568DEFERASIROX TABLET, FOR SUSPENSION [SUN PHARMACEUTICAL INDUSTRIES, INC.]11Current NDC, Legacy NDC, 2 package rows20231227_4a2e1bd2-9f3a-40ec-94a2-bc76350d6d4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597768deferasirox 125 MG Tablet for Oral SuspensionPSN4a2e1bd2-9f3a-40ec-94a2-bc76350d6d4b11
597770deferasirox 250 MG Tablet for Oral SuspensionPSN4a2e1bd2-9f3a-40ec-94a2-bc76350d6d4b11
597772deferasirox 500 MG Tablet for Oral SuspensionPSN4a2e1bd2-9f3a-40ec-94a2-bc76350d6d4b11
597768deferasirox 125 MG Tablet for Oral SuspensionSCD4a2e1bd2-9f3a-40ec-94a2-bc76350d6d4b11
597770deferasirox 250 MG Tablet for Oral SuspensionSCD4a2e1bd2-9f3a-40ec-94a2-bc76350d6d4b11
597772deferasirox 500 MG Tablet for Oral SuspensionSCD4a2e1bd2-9f3a-40ec-94a2-bc76350d6d4b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62756-568-836275605688330 TABLET, FOR SUSPENSION in 1 BOTTLE (62756-568-83) 2019-12-020000-00-00NoNoCurrent
62756-568-866275605688660 TABLET, FOR SUSPENSION in 1 BOTTLE (62756-568-86) 2019-12-020000-00-00NoNoCurrent