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United States · US · US:0078-1035_6993f70f-a922-4520-9537-ec6cea3bd915
VIJOICE
Orange BookSPL
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 · 2
- ndc1100781035022 BLISTER PACK in 1 CARTON (0078-1035-02) / 1 KIT in 1 BLISTER PACK (0078-1035-61)
- ndc1100781035922 BLISTER PACK in 1 CARTON (0078-1035-92) / 1 KIT in 1 BLISTER PACK (0078-1035-94)
Annotations
Orange Book
N215039
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"638069a4-aee0-46c9-9e21-54ad449c163c": {
"match": "brand_token",
"title": "VIJOICE (ALPELISIB) TABLET VIJOICE (ALPELISIB) KIT VIJOICE (ALPELISIB) GRANULE [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "10",
"published_date": "2025-11-17"
}
},
"productid": "0078-1035_6993f70f-a922-4520-9537-ec6cea3bd915",
"productndc": "0078-1035",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "215039",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "50MG",
"product_no": "001",
"approval_date": "Apr 5, 2022"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "125MG",
"product_no": "002",
"approval_date": "Apr 5, 2022"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "200MG",
"product_no": "003",
"approval_date": "Apr 5, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "VIJOICE",
"active_ingred_unit": null,
"application_number": "NDA215039",
"marketing_category": "NDA",
"nonproprietary_name": "alpelisib",
"start_marketing_date": "20220405",
"active_numerator_strength": null
}Access this data programmatically
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