Jynneos Injection, Suspension
NDC Package 50632-001-03

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

Jynneos (vaccinia virus modified strain ankara-bavarian nordic non-replicating antigen) injection is jYNNEOS is a vaccine indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. This formulation utilizes a injection, suspension delivery system. Marketed by Bavarian Nordic A/s, this product is identified by NDC 50632-001 and is authorized under FDA application BLA125678.

Identification & Billing

NDC Package Code
50632-001-03
Package Description
10 VIAL in 1 CARTON / .5 mL in 1 VIAL (50632-001-01)
Product Code
50632-001
11-Digit Billing Format
50632000103
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2464827 - smallpox and monkeypox vaccine, live 0.5 mL Injection
  • RxCUI: 2464827 - 0.5 ML modified Vaccinia Ankara-Bavarian Nordic 198000000 UNT/ML Injection
  • RxCUI: 2464827 - modified Vaccinia Ankara-Bavarian Nordic 198000000 UNT/ML per 0.5 MLInjection
  • RxCUI: 2464827 - modified Vaccinia Ankara-Bavarian Nordic 395000000 UNT per 1 ML Injection
  • RxCUI: 2464827 - MVA-BN 198000000 UNT/ML per 0.5 MLInjection

Clinical Specifications

Proprietary Name
Jynneos
Non-Proprietary Name
Vaccinia Virus Modified Strain Ankara-bavarian Nordic Non-replicating Antigen
Substance Name
Vaccinia Virus Modified Strain Ankara-bavarian Nordic Non-replicating Antigen
Dosage Form
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN 50000000 1/.5mL
Usage Information
JYNNEOS is a vaccine indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.

Regulatory & Marketing

Labeler Name
Bavarian Nordic A/s
Product Type
Vaccine
FDA Application #
BLA125678
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-17-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50632-001). Click a package code to view its specific billing and regulatory data.

50632-001-02
20 VIAL in 1 CARTON / .5 mL in 1 VIAL (50632-001-01)

* 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 50632-001-03 identifies a specific commercial package of 10 vial in 1 carton / .5 ml in 1 vial (50632-001-01) of Jynneos, a vaccine label labeled by Bavarian Nordic A/s. This injection, suspension is formulated for subcutaneous use and contains vaccinia virus modified strain ankara-bavarian nordic non-replicating antigen 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 Bavarian Nordic A/s on March 17, 2021. The current certification is valid through December 31, 2026.

How is this Bavarian Nordic A/s product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50632000103. 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)
50632-001-03
11-Digit CMS (5-4-2)
50632-0001-03

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