Prescription drug · NDA
Piqray (alpelisib) NDC 0078-0708
Alpelisib 150 mg/1 · Tablet · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0708-02 | 00078070802 | 2 BLISTER PACK in 1 CARTON (0078-0708-02) / 28 TABLET in 1 BLISTER PACK (0078-0708-51)Marketed from May 24, 2019 | |
| 0078-0708-91 | 00078070891 | 1 BLISTER PACK in 1 CARTON (0078-0708-91) / 28 TABLET in 1 BLISTER PACK (0078-0708-90)Marketed from May 24, 2019 · Sample package |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Piqray
- Generic name (nonproprietary)
- alpelisib
- Active ingredients
- Alpelisib — 150 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212526
- Marketing start
- Listing expires
- Identifiers
- Product ID 0078-0708_b4a9e0a0-a882-485b-918f-7134992246ceSPL ID b4a9e0a0-a882-485b-918f-7134992246ceSPL set ID b20b4e18-7a4b-4500-a08f-06c6dab0ee5bRxCUI 2169300, 2169307, 2169310, 2169311, 2169313, 2169314, 2169316, 2169318, 2169319, 2169320, 2169321, 2169322UNII 08W5N2C97Q
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400078070802followed by a unit qualifier and the quantityPackage 00078-0708-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
PIQRAY is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. PIQRAY is a kinase inhibitor indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 212526
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.