Deferasirox

Product NDC
67877-550
11-digit product format
678770550
Labeler code
67877
Product ID
67877-550_1a5b6d3f-ad5c-43f7-bed3-4b51ae26f872
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deferasirox
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA210519
Marketing category
ANDA
Marketing start
2019-11-22
Substance
DEFERASIROX
Active strength
250 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
DEFERASIROX250 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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
0feb0248-301d-406d-9b41-7d80ddbec8a8Product name420201216
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-550-30Deferasirox30 in 1 BOTTLETABLET, FOR SUSPENSION3017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-550-30EA - Each67877-5501b0322ca-d9fe-451b-8b8a-7afa556a79f112019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-550DEFERASIROX TABLET, FOR SUSPENSION [ASCEND LABORATORIES, LLC]15Current NDC, Legacy NDC, 1 package rows20220528_da3295fc-5210-46a3-a5cc-7b9ec9265eca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597768deferasirox 125 MG Tablet for Oral SuspensionPSNda3295fc-5210-46a3-a5cc-7b9ec9265eca17
597770deferasirox 250 MG Tablet for Oral SuspensionPSNda3295fc-5210-46a3-a5cc-7b9ec9265eca17
597772deferasirox 500 MG Tablet for Oral SuspensionPSNda3295fc-5210-46a3-a5cc-7b9ec9265eca17
597768deferasirox 125 MG Tablet for Oral SuspensionSCDda3295fc-5210-46a3-a5cc-7b9ec9265eca17
597770deferasirox 250 MG Tablet for Oral SuspensionSCDda3295fc-5210-46a3-a5cc-7b9ec9265eca17
597772deferasirox 500 MG Tablet for Oral SuspensionSCDda3295fc-5210-46a3-a5cc-7b9ec9265eca17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-550-306787705503030 TABLET, FOR SUSPENSION in 1 BOTTLE (67877-550-30) 2019-11-220000-00-00NoNoCurrent