Jadenu

Product NDC
0078-0727
11-digit product format
000780727
Labeler code
0078
Product ID
0078-0727_028e6158-3b78-41dd-99a8-6acb582f7245
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
deferasirox
Dosage form
GRANULE
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA207968
Marketing category
NDA
Marketing start
2017-05-18
Substance
DEFERASIROX
Active strength
90 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
Jadenu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEFERASIROX90 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV8G4MOF2V9
Rxcui1607784, 1607790, 1607792, 1607794, 1607796, 1607798, 1923822, 1923825, 1923826, 1923827, 1923828, 1923829

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
0078-0727-15Jadenu30 in 1 CARTONGRANULE3026
0078-0727-19Jadenu1 in 1 PACKETGRANULE126

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0727JADENU (DEFERASIROX) TABLET, FILM COATED JADENU (DEFERASIROX) GRANULE [NOVARTIS PHARMACEUTICALS CORPORATION]23Current NDC, Legacy NDC, 2 package rows20250503_fee89140-fff1-4443-9f42-24ac004fcda1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923828deferasirox 180 MG Oral GranulesPSNfee89140-fff1-4443-9f42-24ac004fcda126
1607784deferasirox 180 MG Oral TabletPSNfee89140-fff1-4443-9f42-24ac004fcda126
1923826deferasirox 360 MG Oral GranulesPSNfee89140-fff1-4443-9f42-24ac004fcda126
1607792deferasirox 360 MG Oral TabletPSNfee89140-fff1-4443-9f42-24ac004fcda126
1923822deferasirox 90 MG Oral GranulesPSNfee89140-fff1-4443-9f42-24ac004fcda126
1607796deferasirox 90 MG Oral TabletPSNfee89140-fff1-4443-9f42-24ac004fcda126
1607790Jadenu 180 MG Oral TabletPSNfee89140-fff1-4443-9f42-24ac004fcda126
1607794Jadenu 360 MG Oral TabletPSNfee89140-fff1-4443-9f42-24ac004fcda126
1607798Jadenu 90 MG Oral TabletPSNfee89140-fff1-4443-9f42-24ac004fcda126
1923829Jadenu Sprinkle 180 MG Oral GranulesPSNfee89140-fff1-4443-9f42-24ac004fcda126
1923827Jadenu Sprinkle 360 MG Oral GranulesPSNfee89140-fff1-4443-9f42-24ac004fcda126
1923825Jadenu Sprinkle 90 MG Oral GranulesPSNfee89140-fff1-4443-9f42-24ac004fcda126
1923829deferasirox 180 MG Oral Granules [Jadenu]SBDfee89140-fff1-4443-9f42-24ac004fcda126
1607790deferasirox 180 MG Oral Tablet [Jadenu]SBDfee89140-fff1-4443-9f42-24ac004fcda126
1923827deferasirox 360 MG Oral Granules [Jadenu]SBDfee89140-fff1-4443-9f42-24ac004fcda126
1607794deferasirox 360 MG Oral Tablet [Jadenu]SBDfee89140-fff1-4443-9f42-24ac004fcda126
1923825deferasirox 90 MG Oral Granules [Jadenu]SBDfee89140-fff1-4443-9f42-24ac004fcda126
1607798deferasirox 90 MG Oral Tablet [Jadenu]SBDfee89140-fff1-4443-9f42-24ac004fcda126
1923828deferasirox 180 MG Oral GranulesSCDfee89140-fff1-4443-9f42-24ac004fcda126
1607784deferasirox 180 MG Oral TabletSCDfee89140-fff1-4443-9f42-24ac004fcda126
1923826deferasirox 360 MG Oral GranulesSCDfee89140-fff1-4443-9f42-24ac004fcda126
1607792deferasirox 360 MG Oral TabletSCDfee89140-fff1-4443-9f42-24ac004fcda126
1923822deferasirox 90 MG Oral GranulesSCDfee89140-fff1-4443-9f42-24ac004fcda126
1607796deferasirox 90 MG Oral TabletSCDfee89140-fff1-4443-9f42-24ac004fcda126
1923829Jadenu 180 MG Oral GranulesSYfee89140-fff1-4443-9f42-24ac004fcda126
1607790Jadenu 180 MG Oral TabletSYfee89140-fff1-4443-9f42-24ac004fcda126
1923827Jadenu 360 MG Oral GranulesSYfee89140-fff1-4443-9f42-24ac004fcda126
1607794Jadenu 360 MG Oral TabletSYfee89140-fff1-4443-9f42-24ac004fcda126
1923825Jadenu 90 MG Oral GranulesSYfee89140-fff1-4443-9f42-24ac004fcda126
1607798Jadenu 90 MG Oral TabletSYfee89140-fff1-4443-9f42-24ac004fcda126

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0727-150007807271530 PACKET in 1 CARTON (0078-0727-15) / 1 GRANULE in 1 PACKET (0078-0727-19) 30 packet2017-05-180000-00-00NoNoCurrent
0078-0727-19000780727191 in 1 PACKETHistorical