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United States · US · US:0078-0715_b4a9e0a0-a882-485b-918f-7134992246ce
PIQRAY
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
- ndc1100780715022 KIT in 1 CARTON (0078-0715-02) / 1 KIT in 1 KIT (0078-0715-61) * 14 TABLET in 1 BLISTER PACK * 14 TABLET in 1 BLISTER PACK
- ndc1100780715911 KIT in 1 CARTON (0078-0715-91) / 1 KIT in 1 KIT (0078-0715-94) * 14 TABLET in 1 BLISTER PACK * 14 TABLET in 1 BLISTER PACK
Annotations
Orange Book
N212526
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"b20b4e18-7a4b-4500-a08f-06c6dab0ee5b": {
"match": "brand_token",
"title": "PIQRAY (ALPELISIB) TABLET PIQRAY (ALPELISIB) KIT [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "13",
"published_date": "2025-12-16"
}
},
"productid": "0078-0715_b4a9e0a0-a882-485b-918f-7134992246ce",
"productndc": "0078-0715",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "212526",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "50MG",
"product_no": "001",
"approval_date": "May 24, 2019"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "150MG",
"product_no": "002",
"approval_date": "May 24, 2019"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "200MG",
"product_no": "003",
"approval_date": "May 24, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "PIQRAY",
"active_ingred_unit": null,
"application_number": "NDA212526",
"marketing_category": "NDA",
"nonproprietary_name": "alpelisib",
"start_marketing_date": "20190524",
"active_numerator_strength": null
}Access this data programmatically
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