Piqray Tablet
NDC Package 0078-0708-91

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Piqray (alpelisib) tablets is a medication used to treat certain types of breast cancer. This formulation utilizes a tablet delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0708 and is authorized under FDA application NDA212526.

Identification & Billing

NDC Package Code
0078-0708-91
Package Description
1 BLISTER PACK in 1 CARTON / 28 TABLET in 1 BLISTER PACK (0078-0708-90)
Product Code
0078-0708
11-Digit Billing Format
00078070891
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Piqray
Non-Proprietary Name
Alpelisib
Substance Name
Alpelisib
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ALPELISIB 150 mg/1
Usage Information
This medication is used to treat certain types of breast cancer. Alpelisib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA212526
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-24-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0078-0708). Click a package code to view its specific billing and regulatory data.

0078-0708-02
2 BLISTER PACK in 1 CARTON / 28 TABLET in 1 BLISTER PACK (0078-0708-51)

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0078-0708-91 identifies a specific commercial package of 1 blister pack in 1 carton / 28 tablet in 1 blister pack (0078-0708-90) of Piqray, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This tablet is formulated for oral use and contains alpelisib as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Novartis Pharmaceuticals Corporation on May 24, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain types of breast cancer. Alpelisib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078070891. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0078-0708-91
11-Digit CMS (5-4-2)
00078-0708-91

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.