NDC 0078-0708

PIQRAY

Alpelisib

PIQRAY is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Alpelisib.

Product ID0078-0708_0966a539-f6fd-4cab-9d30-152f48583edd
NDC0078-0708
Product TypeHuman Prescription Drug
Proprietary NamePIQRAY
Generic NameAlpelisib
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-05-24
Marketing CategoryNDA / NDA
Application NumberNDA212526
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameALPELISIB
Active Ingredient Strength150 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0078-0708-02

2 BLISTER PACK in 1 CARTON (0078-0708-02) > 28 TABLET in 1 BLISTER PACK (0078-0708-51)
Marketing Start Date2019-05-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0708-90 [00078070890]

PIQRAY TABLET
Marketing CategoryNDA
Application NumberNDA212526
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-24

NDC 0078-0708-02 [00078070802]

PIQRAY TABLET
Marketing CategoryNDA
Application NumberNDA212526
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-24

NDC 0078-0708-51 [00078070851]

PIQRAY TABLET
Marketing CategoryNDA
Application NumberNDA212526
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-24

NDC 0078-0708-91 [00078070891]

PIQRAY TABLET
Marketing CategoryNDA
Application NumberNDA212526
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-24

Drug Details

Active Ingredients

IngredientStrength
ALPELISIB150 mg/1

OpenFDA Data

SPL SET ID:b20b4e18-7a4b-4500-a08f-06c6dab0ee5b
Manufacturer
UNII

NDC Crossover Matching brand name "PIQRAY" or generic name "Alpelisib"

NDCBrand NameGeneric Name
0078-0701PIQRAYalpelisib
0078-0708PIQRAYalpelisib
0078-0715PIQRAYalpelisib
0078-1021VIJOICEalpelisib
0078-1028VIJOICEalpelisib
0078-1035VIJOICEalpelisib

Trademark Results [PIQRAY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PIQRAY
PIQRAY
86279420 not registered Dead/Abandoned
Novartis AG
2014-05-13
PIQRAY
PIQRAY
79219218 5415224 Live/Registered
NOVARTIS AG
2017-08-23

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