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United States · US · US:0078-0656_028e6158-3b78-41dd-99a8-6acb582f7245
Jadenu
Orange BookUNIISPLATC V03AC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeV03AC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11007806561530 TABLET, FILM COATED in 1 BOTTLE (0078-0656-15)
Annotations
UNII (FDA Substance ID)
V8G4MOF2V9
DEFERASIROX
RxCUI 614373
Orange Book
N206910
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "V8G4MOF2V9",
"rxcui": "614373",
"inchikey": "BOFQWVMAQOTZIW-UHFFFAOYSA-N",
"display_name": "DEFERASIROX",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"fee89140-fff1-4443-9f42-24ac004fcda1": {
"match": "brand_token",
"title": "JADENU (DEFERASIROX) TABLET, FILM COATED JADENU (DEFERASIROX) GRANULE [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "26",
"published_date": "2025-12-12"
}
},
"productid": "0078-0656_028e6158-3b78-41dd-99a8-6acb582f7245",
"productndc": "0078-0656",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "206910",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "90MG",
"product_no": "001",
"approval_date": "Mar 30, 2015"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "180MG",
"product_no": "002",
"approval_date": "Mar 30, 2015"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "360MG",
"product_no": "003",
"approval_date": "Mar 30, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEFERASIROX",
"proprietary_name": "Jadenu",
"active_ingred_unit": "mg/1",
"application_number": "NDA206910",
"marketing_category": "NDA",
"nonproprietary_name": "deferasirox",
"start_marketing_date": "20150330",
"active_numerator_strength": "360"
}Related drugs
Other records sharing ATC code V03AC03.
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