Wainua Injection, Solution
NDC Package 0310-9400-01

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

Package Information

Wainua (eplontersen) injection is wAINUA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. This formulation utilizes a injection, solution delivery system. Marketed by Astrazeneca Pharmaceuticals Lp, this product is identified by NDC 0310-9400 and is authorized under FDA application NDA217388.

Identification & Billing

NDC Package Code
0310-9400-01
Package Description
1 SYRINGE, GLASS in 1 CARTON / .8 mL in 1 SYRINGE, GLASS
Product Code
0310-9400
11-Digit Billing Format
00310940001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Wainua
Non-Proprietary Name
Eplontersen
Substance Name
Eplontersen
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)
EPLONTERSEN 45 mg/.8mL
Pharmacologic Class
Usage Information
WAINUA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

Regulatory & Marketing

Labeler Name
Astrazeneca Pharmaceuticals Lp
Product Type
Human Prescription Drug
FDA Application #
NDA217388
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-21-2023
Listing Expiration
12-31-2027
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 0310-9400-01 identifies a specific commercial package of 1 syringe, glass in 1 carton / .8 ml in 1 syringe, glass of Wainua, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. This injection, solution is formulated for subcutaneous use and contains eplontersen 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 Astrazeneca Pharmaceuticals Lp on December 21, 2023. The current certification is valid through December 31, 2027.

How is this Astrazeneca Pharmaceuticals Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00310940001. 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 (4-4-2)
0310-9400-01
11-Digit CMS (5-4-2)
00310-9400-01

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