piqray

Generic: alpelisib

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name piqray
Generic Name alpelisib
Labeler novartis pharmaceuticals corporation
Dosage Form KIT
Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0715
Product ID 0078-0715_b4a9e0a0-a882-485b-918f-7134992246ce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212526
Listing Expiration 2026-12-31
Marketing Start 2019-05-24

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780715
Hyphenated Format 0078-0715

Supplemental Identifiers

RxCUI
2169300 2169307 2169310 2169311 2169313 2169314 2169316 2169318 2169319 2169320 2169321 2169322
UNII
08W5N2C97Q

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name piqray (source: ndc)
Generic Name alpelisib (source: ndc)
Application Number NDA212526 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 50 mg
  • 150 mg
  • 200 mg
  • 300 mg
  • 250 mg
source: label
Packaging
  • 2 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
  • 1 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
source: ndc

Packages (2)

0078-0715-02 2 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 0078-0715-91 1 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

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

PIQRAY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "b4a9e0a0-a882-485b-918f-7134992246ce", "openfda": {"unii": ["08W5N2C97Q"], "rxcui": ["2169300", "2169307", "2169310", "2169311", "2169313", "2169314", "2169316", "2169318", "2169319", "2169320", "2169321", "2169322"], "spl_set_id": ["b20b4e18-7a4b-4500-a08f-06c6dab0ee5b"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 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", "package_ndc": "0078-0715-02", "marketing_start_date": "20190524"}, {"sample": true, "description": "1 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", "package_ndc": "0078-0715-91", "marketing_start_date": "20190524"}], "brand_name": "PIQRAY", "product_id": "0078-0715_b4a9e0a0-a882-485b-918f-7134992246ce", "dosage_form": "KIT", "product_ndc": "0078-0715", "generic_name": "alpelisib", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PIQRAY", "application_number": "NDA212526", "marketing_category": "NDA", "marketing_start_date": "20190524", "listing_expiration_date": "20261231"}