Zontivity
NDC Package 70347-208-90

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Zontivity is vorapaxar is used to help prevent heart attacks and strokes in people who have had a heart attack or have poor blood flow (peripheral arterial disease). Marketed by Aralez Pharmaceuticals Us Inc., this product is identified by NDC 70347-208 and is authorized under FDA application NDA204886.

Identification & Billing

NDC Package Code
70347-208-90
Package Description
90 TABLET, FILM COATED in 1 BOTTLE
Product Code
70347-208
11-Digit Billing Format
70347020890
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zontivity
Dosage Form
-
Usage Information
Vorapaxar is used to help prevent heart attacks and strokes in people who have had a heart attack or have poor blood flow (peripheral arterial disease). It works by blocking certain blood cells called platelets from sticking together and forming harmful blood clots. Harmful blood clots can cause heart attacks, strokes, and other serious problems. This "anti-platelet" effect helps keep blood flowing smoothly in your body.

Regulatory & Marketing

Labeler Name
Aralez Pharmaceuticals Us Inc.
FDA Application #
NDA204886
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-08-2014
Listing Expiration
12-31-2022
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70347-208). Click a package code to view its specific billing and regulatory data.

70347-208-05
5 TABLET, FILM COATED in 1 BLISTER PACK
70347-208-30
30 TABLET, FILM COATED in 1 BOTTLE

* 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 70347-208-90 identifies a specific commercial package of 90 tablet, film coated in 1 bottle of Zontivity, labeled by Aralez Pharmaceuticals Us Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Aralez Pharmaceuticals Us Inc. on May 08, 2014. The current certification is valid through December 31, 2022.

What are the primary indications for this medication?

Vorapaxar is used to help prevent heart attacks and strokes in people who have had a heart attack or have poor blood flow (peripheral arterial disease). It works by blocking certain blood cells called platelets from sticking together and forming harmful blood clots. Harmful blood clots can cause heart attacks, strokes, and other serious problems. This "anti-platelet" effect helps keep blood flowing smoothly in your body.

How is this Aralez Pharmaceuticals Us Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70347020890. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 total billable units per package. 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 (5-3-2)
70347-208-90
11-Digit CMS (5-4-2)
70347-0208-90

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