Cardamyst Spray
NDC Package 83468-070-03

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

Package Information

Cardamyst (etripamil) sprays is cARDAMYST is indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. This formulation utilizes a spray delivery system. Marketed by Milestone Pharmaceuticals Usa, Inc., this product is identified by NDC 83468-070 and is authorized under FDA application NDA218571.

Identification & Billing

NDC Package Code
83468-070-03
Package Description
2 CONTAINER in 1 CARTON / 2 VIAL, SINGLE-DOSE in 1 CONTAINER (83468-070-02) / .2 mL in 1 VIAL, SINGLE-DOSE (83468-070-01)
Product Code
83468-070
11-Digit Billing Format
83468007003
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cardamyst
Non-Proprietary Name
Etripamil
Substance Name
Etripamil
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
ETRIPAMIL 70 mg/.2mL
Usage Information
CARDAMYST is indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.

Regulatory & Marketing

Labeler Name
Milestone Pharmaceuticals Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA218571
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-05-2026
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 83468-070-03 identifies a specific commercial package of 2 container in 1 carton / 2 vial, single-dose in 1 container (83468-070-02) / .2 ml in 1 vial, single-dose (83468-070-01) of Cardamyst, a human prescription drug labeled by Milestone Pharmaceuticals Usa, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This spray is formulated for nasal use and contains etripamil 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 Milestone Pharmaceuticals Usa, Inc. on January 05, 2026. The current certification is valid through December 31, 2026.

How is this Milestone Pharmaceuticals Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83468007003. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
83468-070-03
11-Digit CMS (5-4-2)
83468-0070-03

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