FDA.reportPublic FDA data

Jadenu

Product NDC
0078-0713
11-digit product format
000780713
Labeler code
0078
Product ID
0078-0713_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
180 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
DEFERASIROX180 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
0078-0713-15Jadenu30 in 1 CARTONGRANULE3026
0078-0713-19Jadenu1 in 1 PACKETGRANULE126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0713-15EA - Each0078-07130ea4f19e-9222-4993-9cf1-9f61540de54f12017-07-07
0078-0713-19EA - Each0078-071354cebb18-44e9-4c76-af0c-46962ded24d312017-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEFERASIROXACTIVE INGREDIENTV8G4MOF2V9JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]4
DEFERASIROXACTIVE MOIETYV8G4MOF2V9JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UJADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKJADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XJADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]4
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGJADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XJADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JJADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0713JADENU (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
0078-0713-150007807131530 PACKET in 1 CARTON (0078-0713-15) / 1 GRANULE in 1 PACKET (0078-0713-19) 30 packet2017-05-180000-00-00NoNoCurrent
0078-0713-19000780713191 in 1 PACKETHistorical