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United States · US · US:0078-1420_af74a97e-160b-4335-9bc5-97a29e721d1b
VANRAFIA
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11007814201530 TABLET, FILM COATED in 1 BOTTLE (0078-1420-15)
Annotations
UNII (FDA Substance ID)
E4G31X93ZA
ATRASENTAN HYDROCHLORIDE
Orange Book
N219208
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "E4G31X93ZA",
"rxcui": null,
"inchikey": "IJFUJIFSUKPWCZ-SQMFDTLJSA-N",
"display_name": "ATRASENTAN HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"9a7e7f85-bfd0-44a0-beda-3bcfa8215c64": {
"match": "brand_token",
"title": "VANRAFIA (ATRASENTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "2",
"published_date": "2025-06-09"
}
},
"productid": "0078-1420_af74a97e-160b-4335-9bc5-97a29e721d1b",
"productndc": "0078-1420",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "219208",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 0.75MG BASE",
"product_no": "001",
"approval_date": "Apr 2, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ATRASENTAN HYDROCHLORIDE",
"proprietary_name": "VANRAFIA",
"active_ingred_unit": "mg/1",
"application_number": "NDA219208",
"marketing_category": "NDA",
"nonproprietary_name": "atrasentan",
"start_marketing_date": "20250402",
"active_numerator_strength": ".75"
}Access this data programmatically
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