Selexipag Titration Pack Kit
NDC Package 70710-1653-7

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

Package Information

Selexipag Titration Pack (selexipag) kits is selexipag is used to treat high blood pressure in the lungs (pulmonary arterial hypertension-PAH). This formulation utilizes a kit delivery system. Marketed by Zydus Pharmaceuticals (usa) Inc., this product is identified by NDC 70710-1653 and is authorized under FDA application ANDA214302.

Identification & Billing

NDC Package Code
70710-1653-7
Package Description
1 KIT in 1 CARTON * 1 BOTTLE in 1 CARTON / 140 TABLET, FILM COATED in 1 BOTTLE (70710-1551-8) * 1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE (70710-1554-6)
Product Code
70710-1653
11-Digit Billing Format
70710165307
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Selexipag Titration Pack
Non-Proprietary Name
Selexipag
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Selexipag is used to treat high blood pressure in the lungs (pulmonary arterial hypertension-PAH). It is used to help slow down worsening of PAH and to decrease the chance of needing treatment in a hospital. Selexipag works by making it easier for blood to flow through the arteries in your lungs. This effect helps increase your ability to exercise.

Regulatory & Marketing

Labeler Name
Zydus Pharmaceuticals (usa) Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA214302
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-14-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70710-1653-7 identifies a specific commercial package of 1 kit in 1 carton * 1 bottle in 1 carton / 140 tablet, film coated in 1 bottle (70710-1551-8) * 1 bottle in 1 carton / 60 tablet, film coated in 1 bottle (70710-1554-6) of Selexipag Titration Pack, a human prescription drug labeled by Zydus Pharmaceuticals (usa) Inc.. This kit is formulated for use and contains 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 Zydus Pharmaceuticals (usa) Inc. on February 14, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Selexipag is used to treat high blood pressure in the lungs (pulmonary arterial hypertension-PAH). It is used to help slow down worsening of PAH and to decrease the chance of needing treatment in a hospital. Selexipag works by making it easier for blood to flow through the arteries in your lungs. This effect helps increase your ability to exercise.

How is this Zydus Pharmaceuticals (usa) Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70710165307. 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 (5-4-1)
70710-1653-7
11-Digit CMS (5-4-2)
70710-1653-07

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