NDC 0078-1035 Vijoice
Alpelisib Kit - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 0078 - Novartis Pharmaceuticals Corporation
- 0078-1035 - Vijoice
Product Characteristics
YELLOW (C48330 - DARK)
YELLOW (C48330 - PALE)
OVAL (C48345)
13 MM
16 MM
Y7;NVR
CL7;NVR
Product Packages
NDC Code 0078-1035-02
Package Description: 2 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK (0078-1035-61)
NDC Code 0078-1035-92
Package Description: 2 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK (0078-1035-94)
Product Details
What is NDC 0078-1035?
What are the uses for Vijoice?
Which are Vijoice UNII Codes?
The UNII codes for the active ingredients in this product are:
- ALPELISIB (UNII: 08W5N2C97Q)
- ALPELISIB (UNII: 08W5N2C97Q) (Active Moiety)
Which are Vijoice Inactive Ingredients UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- MANNITOL (UNII: 3OWL53L36A)
- SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
- HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- TALC (UNII: 7SEV7J4R1U)
- POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- FERRIC OXIDE RED (UNII: 1K09F3G675)
- FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
What is the NDC to RxNorm Crosswalk for Vijoice?
- RxCUI: 2169310 - alpelisib 200 MG Oral Tablet
- RxCUI: 2169316 - alpelisib 50 MG Oral Tablet
- RxCUI: 2169319 - {28 (alpelisib 200 MG Oral Tablet) / 28 (alpelisib 50 MG Oral Tablet) } Pack
- RxCUI: 2169319 - alpelisib 200 MG (28) Oral Tablet / alpelisib 50 MG Oral Tablet (28) Oral Tablet, 250 MG Daily Dose Pack
- RxCUI: 2598459 - Vijoice 50 MG Oral Tablet
* Please review the disclaimer below.
Patient Education
Alpelisib
Alpelisib (Piqray) is used in combination with fulvestrant (Faslodex) to treat a certain type of breast cancer that has spread to nearby tissues or other parts of the body in women who have already gone through menopause (''change of life,'' end of menstrual periods) or in men, whose cancer got worse during or after certain other treatments. Alpelisib (Vijoice) is used to treat adults and children 2 years of age or older who have certain types of PIK3CA Related Overgrowth Spectrum (PROS; a genetic condition that causes overgrowth and abnormalities in certain body tissues). Alpelisib is in a class of medications called kinase inhibitors. It works to treat cancer by blocking the signals that cause cancer cells to multiply, which helps to stop the spread of cancer cells. It works to treast PROS by blocking the signals that cause overgrowth and abnormalities in certain body tissues, which reduces the size of the overgrowths and improves symptoms.
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* Please review the disclaimer below.
[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.
[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".