NDC 0078-0701

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 ID: 0078-0701_0966a539-f6fd-4cab-9d30-152f48583edd
• NDC: 0078-0701
• Product Type: Human Prescription Drug
• Proprietary Name: PIQRAY
• Generic Name: Alpelisib
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2019-05-24
• Marketing Category: NDA / NDA
• Application Number: NDA212526
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: ALPELISIB
• Active Ingredient Strength: 200 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0078-0701-84

1 BLISTER PACK in 1 CARTON (0078-0701-84) > 28 TABLET in 1 BLISTER PACK (0078-0701-51)

• Marketing Start Date: 2019-05-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0701-51 [00078070151]

PIQRAY TABLET

• Marketing Category: NDA
• Application Number: NDA212526
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-05-24

NDC 0078-0701-84 [00078070184]

PIQRAY TABLET

• Marketing Category: NDA
• Application Number: NDA212526
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-05-24

Drug Details

Active Ingredients

Ingredient	Strength
ALPELISIB	200 mg/1

OpenFDA Data

• SPL SET ID: b20b4e18-7a4b-4500-a08f-06c6dab0ee5b
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 08W5N2C97Q

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

NDC	Brand Name	Generic Name
0078-0701	PIQRAY	alpelisib
0078-0708	PIQRAY	alpelisib
0078-0715	PIQRAY	alpelisib
0078-1021	VIJOICE	alpelisib
0078-1028	VIJOICE	alpelisib
0078-1035	VIJOICE	alpelisib