vijoice

Generic: alpelisib

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

Drug Facts

Product Profile

Brand Name vijoice
Generic Name alpelisib
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET
Routes
ORAL
Active Ingredients

alpelisib 125 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-1028
Product ID 0078-1028_6993f70f-a922-4520-9537-ec6cea3bd915
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215039
Listing Expiration 2026-12-31
Marketing Start 2022-04-05

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00781028
Hyphenated Format 0078-1028

Supplemental Identifiers

RxCUI
2169310 2169316 2169319 2598459 2598461 2598463 2598464 2598465 2598466 2598467 2598469 2598470 2680135 2680138 2680139 2680140
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 vijoice (source: ndc)
Generic Name alpelisib (source: ndc)
Application Number NDA215039 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (0078-1028-84) / 28 TABLET in 1 BLISTER PACK (0078-1028-51)
  • 1 BLISTER PACK in 1 CARTON (0078-1028-91) / 28 TABLET in 1 BLISTER PACK (0078-1028-90)
source: ndc

Packages (2)

0078-1028-84 1 BLISTER PACK in 1 CARTON (0078-1028-84) / 28 TABLET in 1 BLISTER PACK (0078-1028-51) 0078-1028-91 1 BLISTER PACK in 1 CARTON (0078-1028-91) / 28 TABLET in 1 BLISTER PACK (0078-1028-90)

Ingredients (1)

alpelisib (125 mg/1)

Linked Drug Pages (1)

VIJOICE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6993f70f-a922-4520-9537-ec6cea3bd915", "openfda": {"unii": ["08W5N2C97Q"], "rxcui": ["2169310", "2169316", "2169319", "2598459", "2598461", "2598463", "2598464", "2598465", "2598466", "2598467", "2598469", "2598470", "2680135", "2680138", "2680139", "2680140"], "spl_set_id": ["638069a4-aee0-46c9-9e21-54ad449c163c"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0078-1028-84)  / 28 TABLET in 1 BLISTER PACK (0078-1028-51)", "package_ndc": "0078-1028-84", "marketing_start_date": "20220405"}, {"sample": true, "description": "1 BLISTER PACK in 1 CARTON (0078-1028-91)  / 28 TABLET in 1 BLISTER PACK (0078-1028-90)", "package_ndc": "0078-1028-91", "marketing_start_date": "20220405"}], "brand_name": "VIJOICE", "product_id": "0078-1028_6993f70f-a922-4520-9537-ec6cea3bd915", "dosage_form": "TABLET", "product_ndc": "0078-1028", "generic_name": "alpelisib", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VIJOICE", "active_ingredients": [{"name": "ALPELISIB", "strength": "125 mg/1"}], "application_number": "NDA215039", "marketing_category": "NDA", "marketing_start_date": "20220405", "listing_expiration_date": "20261231"}