Dengvaxia Kit
NDC Package 49281-605-01

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

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Dengvaxia (dengue tetravalent vaccine, live) kits is dENGVAXIA® (Dengue Tetravalent Vaccine, Live) is a vaccine indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4. This formulation utilizes a kit delivery system. Marketed by Sanofi Vaccines Us Inc., this product is identified by NDC 49281-605 and is authorized under FDA application BLA125682.

Identification & Billing

NDC Package Code
49281-605-01
Package Description
1 KIT in 1 CARTON * .5 mL in 1 VIAL, SINGLE-DOSE (49281-606-58) * .6 mL in 1 VIAL, SINGLE-DOSE (49281-549-58)
Product Code
49281-605
11-Digit Billing Format
49281060501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk
  • RxCUI: 2197701 - dengue tetravalent vaccine live 0.5 mL Injection
  • RxCUI: 2197701 - dengue virus live antigen, CYD serotype 1 100000 UNT / dengue virus live antigen, CYD serotype 2 100000 UNT / dengue virus live antigen, CYD serotype 3 100000 UNT / dengue virus live antigen, CYD serotype 4 100000 UNT Injection
  • RxCUI: 2197701 - dengue tetravalent vaccine live 0.5 ML Injection
  • RxCUI: 2197703 - dengvaxia tetravalent vaccine live 0.5 ML Injection
  • RxCUI: 2197703 - dengue virus live antigen, CYD serotype 1 100000 UNT / dengue virus live antigen, CYD serotype 2 100000 UNT / dengue virus live antigen, CYD serotype 3 100000 UNT / dengue virus live antigen, CYD serotype 4 100000 UNT Injection [Dengvaxia]

Clinical Specifications

Proprietary Name
Dengvaxia
Non-Proprietary Name
Dengue Tetravalent Vaccine, Live
Dosage Form
Kit - A packaged collection of related material.
Usage Information
DENGVAXIA® (Dengue Tetravalent Vaccine, Live) is a vaccine indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4. DENGVAXIA is approved for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.

Regulatory & Marketing

Labeler Name
Sanofi Vaccines Us Inc.
Product Type
Vaccine
FDA Application #
BLA125682
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-01-2019
End Marketing Date
08-31-2026
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 49281-605-01 identifies a specific commercial package of 1 kit in 1 carton * .5 ml in 1 vial, single-dose (49281-606-58) * .6 ml in 1 vial, single-dose (49281-549-58) of Dengvaxia, a vaccine label labeled by Sanofi Vaccines Us Inc.. This kit is formulated for use and contains 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 Sanofi Vaccines Us Inc. on May 01, 2019.

How is this Sanofi Vaccines Us Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49281060501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
49281-605-01
11-Digit CMS (5-4-2)
49281-0605-01

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