Dawnzera Injection, Solution
NDC Package 71860-103-01

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

Package Information

Dawnzera (donidalorsen) injection is dAWNZERA™ is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. This formulation utilizes a injection, solution delivery system. Marketed by Ionis Pharmaceuticals Inc., this product is identified by NDC 71860-103 and is authorized under FDA application NDA219407.

Identification & Billing

NDC Package Code
71860-103-01
Package Description
1 SYRINGE, GLASS in 1 CARTON / .8 mL in 1 SYRINGE, GLASS
Product Code
71860-103
11-Digit Billing Format
71860010301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dawnzera
Non-Proprietary Name
Donidalorsen
Substance Name
Donidalorsen Sodium
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
DONIDALORSEN SODIUM 80 mg/.8mL
Usage Information
DAWNZERA™ is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older.

Regulatory & Marketing

Labeler Name
Ionis Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA219407
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-21-2025
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 71860-103-01 identifies a specific commercial package of 1 syringe, glass in 1 carton / .8 ml in 1 syringe, glass of Dawnzera, a human prescription drug labeled by Ionis Pharmaceuticals Inc.. This injection, solution is formulated for subcutaneous use and contains donidalorsen sodium 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 Ionis Pharmaceuticals Inc. on August 21, 2025. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71860010301. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
71860-103-01
11-Digit CMS (5-4-2)
71860-0103-01

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