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United States · US · US:0078-1028_6993f70f-a922-4520-9537-ec6cea3bd915
VIJOICE
Orange BookUNIISPLATC L01EM03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeL01EM03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1100781028841 BLISTER PACK in 1 CARTON (0078-1028-84) / 28 TABLET in 1 BLISTER PACK (0078-1028-51)
- ndc1100781028911 BLISTER PACK in 1 CARTON (0078-1028-91) / 28 TABLET in 1 BLISTER PACK (0078-1028-90)
Annotations
UNII (FDA Substance ID)
08W5N2C97Q
ALPELISIB
RxCUI 2169285
Orange Book
N215039
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "08W5N2C97Q",
"rxcui": "2169285",
"inchikey": "STUWGJZDJHPWGZ-LBPRGKRZSA-N",
"display_name": "ALPELISIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"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": "0078-1028_6993f70f-a922-4520-9537-ec6cea3bd915",
"productndc": "0078-1028",
"dosage_form": "TABLET",
"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": "ALPELISIB",
"proprietary_name": "VIJOICE",
"active_ingred_unit": "mg/1",
"application_number": "NDA215039",
"marketing_category": "NDA",
"nonproprietary_name": "alpelisib",
"start_marketing_date": "20220405",
"active_numerator_strength": "125"
}Related drugs
Other records sharing ATC code L01EM03.
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