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United States · US · US:0078-0708_b4a9e0a0-a882-485b-918f-7134992246ce
PIQRAY
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
- ndc1100780708022 BLISTER PACK in 1 CARTON (0078-0708-02) / 28 TABLET in 1 BLISTER PACK (0078-0708-51)
- ndc1100780708911 BLISTER PACK in 1 CARTON (0078-0708-91) / 28 TABLET in 1 BLISTER PACK (0078-0708-90)
Annotations
UNII (FDA Substance ID)
08W5N2C97Q
ALPELISIB
RxCUI 2169285
Orange Book
N212526
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": {
"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": "0078-0708_b4a9e0a0-a882-485b-918f-7134992246ce",
"productndc": "0078-0708",
"dosage_form": "TABLET",
"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": "ALPELISIB",
"proprietary_name": "PIQRAY",
"active_ingred_unit": "mg/1",
"application_number": "NDA212526",
"marketing_category": "NDA",
"nonproprietary_name": "alpelisib",
"start_marketing_date": "20190524",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code L01EM03.
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