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NDC 00078-0701-84 PIQRAY 200 mg/1 Details
PIQRAY 200 mg/1
PIQRAY is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is ALPELISIB.
MedlinePlus Drug Summary
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.
Related Packages: 00078-0701-84Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Alpelisib
Product Information
| NDC | 00078-0701 |
|---|---|
| Product ID | 0078-0701_5794379a-4b10-4825-a07b-6d0e06fd657f |
| Associated GPIs | 2153801000B720 |
| GCN Sequence Number | 079791 |
| GCN Sequence Number Description | alpelisib TABLET 200 MG/DAY ORAL |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 46362 |
| HICL Sequence Number | 045761 |
| HICL Sequence Number Description | ALPELISIB |
| Brand/Generic | Brand |
| Proprietary Name | PIQRAY |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | alpelisib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | ALPELISIB |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA212526 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00078-0701-84 (00078070184)
| NDC Package Code | 0078-0701-84 |
|---|---|
| Billing NDC | 00078070184 |
| Package | 1 BLISTER PACK in 1 CARTON (0078-0701-84) / 28 TABLET in 1 BLISTER PACK (0078-0701-51) |
| Marketing Start Date | 2019-05-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |