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 TABLET
Routes
ORAL
Active Ingredients

alpelisib 200 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0701
Product ID 0078-0701_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 00780701
Hyphenated Format 0078-0701

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: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (0078-0701-84) / 28 TABLET in 1 BLISTER PACK (0078-0701-51)
source: ndc

Packages (1)

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

Ingredients (1)

alpelisib (200 mg/1)

Linked Drug Pages (1)

PIQRAY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "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": "1 BLISTER PACK in 1 CARTON (0078-0701-84)  / 28 TABLET in 1 BLISTER PACK (0078-0701-51)", "package_ndc": "0078-0701-84", "marketing_start_date": "20190524"}], "brand_name": "PIQRAY", "product_id": "0078-0701_b4a9e0a0-a882-485b-918f-7134992246ce", "dosage_form": "TABLET", "product_ndc": "0078-0701", "generic_name": "alpelisib", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PIQRAY", "active_ingredients": [{"name": "ALPELISIB", "strength": "200 mg/1"}], "application_number": "NDA212526", "marketing_category": "NDA", "marketing_start_date": "20190524", "listing_expiration_date": "20261231"}