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United States · US · US:0078-0468_17c39217-5502-420d-8d2e-799626756189
Exjade
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
- ndc11007804681530 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-0468-15)
Annotations
UNII (FDA Substance ID)
V8G4MOF2V9
DEFERASIROX
RxCUI 614373
Orange Book
N021882
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": {
"3495a70c-870c-4968-940e-8baea152cf85": {
"match": "brand_token",
"title": "EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "49",
"published_date": "2026-01-30"
}
},
"productid": "0078-0468_17c39217-5502-420d-8d2e-799626756189",
"productndc": "0078-0468",
"dosage_form": "TABLET, FOR SUSPENSION",
"orange_book": {
"appl_no": "021882",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "125MG",
"product_no": "001",
"approval_date": "Nov 2, 2005"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "250MG",
"product_no": "002",
"approval_date": "Nov 2, 2005"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "500MG",
"product_no": "003",
"approval_date": "Nov 2, 2005"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEFERASIROX",
"proprietary_name": "Exjade",
"active_ingred_unit": "mg/1",
"application_number": "NDA021882",
"marketing_category": "NDA",
"nonproprietary_name": "deferasirox",
"start_marketing_date": "20051130",
"active_numerator_strength": "125"
}Related drugs
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