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 KIT
Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-1035
Product ID 0078-1035_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 00781035
Hyphenated Format 0078-1035

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: label

Resolved Composition

Strengths
  • 50 mg
  • 125 mg
  • 200 mg
  • 250 mg
source: label
Packaging
  • 2 BLISTER PACK in 1 CARTON (0078-1035-02) / 1 KIT in 1 BLISTER PACK (0078-1035-61)
  • 2 BLISTER PACK in 1 CARTON (0078-1035-92) / 1 KIT in 1 BLISTER PACK (0078-1035-94)
source: ndc

Packages (2)

0078-1035-02 2 BLISTER PACK in 1 CARTON (0078-1035-02) / 1 KIT in 1 BLISTER PACK (0078-1035-61) 0078-1035-92 2 BLISTER PACK in 1 CARTON (0078-1035-92) / 1 KIT in 1 BLISTER PACK (0078-1035-94)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

VIJOICE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"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": "2 BLISTER PACK in 1 CARTON (0078-1035-02)  / 1 KIT in 1 BLISTER PACK (0078-1035-61)", "package_ndc": "0078-1035-02", "marketing_start_date": "20220405"}, {"sample": true, "description": "2 BLISTER PACK in 1 CARTON (0078-1035-92)  / 1 KIT in 1 BLISTER PACK (0078-1035-94)", "package_ndc": "0078-1035-92", "marketing_start_date": "20220405"}], "brand_name": "VIJOICE", "product_id": "0078-1035_6993f70f-a922-4520-9537-ec6cea3bd915", "dosage_form": "KIT", "product_ndc": "0078-1035", "generic_name": "alpelisib", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VIJOICE", "application_number": "NDA215039", "marketing_category": "NDA", "marketing_start_date": "20220405", "listing_expiration_date": "20261231"}