FDA.reportPublic FDA data

Deferasirox oral

Product NDC
67877-677
11-digit product format
678770677
Labeler code
67877
Product ID
67877-677_65865f16-a960-4a42-b0b6-05ab2885bf41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deferasirox oral
Dosage form
GRANULE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA213374
Marketing category
ANDA
Marketing start
2020-07-16
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 oral
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEFERASIROX360 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV8G4MOF2V9
Rxcui1923822, 1923826, 1923828

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
67877-677-73Deferasirox oral1 in 1 PACKETGRANULE17
67877-677-84Deferasirox oral30 in 1 CARTONGRANULE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-677-73EA - Each67877-67786f115aa-3793-4b80-9312-a641e57aebea12022-06-06
67877-677-84EA - Each67877-677a05d3608-3e55-4993-a30d-5b260408778612020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-677DEFERASIROX ORAL GRANULE [ASCEND LABORATORIES, LLC]7Current NDC, Legacy NDC, 2 package rows20220413_2c2842a0-7781-4047-84cd-88bd018e10c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923828deferasirox 180 MG Oral GranulesPSN2c2842a0-7781-4047-84cd-88bd018e10c77
1923826deferasirox 360 MG Oral GranulesPSN2c2842a0-7781-4047-84cd-88bd018e10c77
1923822deferasirox 90 MG Oral GranulesPSN2c2842a0-7781-4047-84cd-88bd018e10c77
1923828deferasirox 180 MG Oral GranulesSCD2c2842a0-7781-4047-84cd-88bd018e10c77
1923826deferasirox 360 MG Oral GranulesSCD2c2842a0-7781-4047-84cd-88bd018e10c77
1923822deferasirox 90 MG Oral GranulesSCD2c2842a0-7781-4047-84cd-88bd018e10c77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-677-73678770677731 in 1 PACKETHistorical
67877-677-846787706778430 PACKET in 1 CARTON (67877-677-84) / 1 GRANULE in 1 PACKET (67877-677-73) 30 packet2020-07-160000-00-00NoNoCurrent