Cyfendus Injection, Suspension
NDC Package 71665-001-02

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

Package Information

Cyfendus (anthrax vaccine adsorbed, adjuvanted) injection is cYFENDUS (Anthrax Vaccine Adsorbed, Adjuvanted) is a vaccine indicated for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. This formulation utilizes a injection, suspension delivery system. Marketed by Emergent Product Development Gaithersburg Inc., this product is identified by NDC 71665-001 and is authorized under FDA application BLA125761.

Identification & Billing

NDC Package Code
71665-001-02
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE (71665-001-01)
Product Code
71665-001
11-Digit Billing Format
71665000102
RxNorm Crosswalk
  • RxCUI: 2665609 - CYFENDUS 0.1 MG/ML Injectable Suspension
  • RxCUI: 2665609 - Bacillus anthracis strain V770-NP1-R antigens 0.1 MG/ML Injectable Suspension [Cyfendus]
  • RxCUI: 2665609 - Cyfendus 0.1 MG/ML Injectable Suspension
  • RxCUI: 832679 - Bacillus anthracis strain V770-NP1-R antigens 0.1 MG/mL Injectable Suspension
  • RxCUI: 832679 - Bacillus anthracis strain V770-NP1-R antigens 0.1 MG/ML Injectable Suspension

Clinical Specifications

Proprietary Name
Cyfendus
Non-Proprietary Name
Anthrax Vaccine Adsorbed, Adjuvanted
Substance Name
Bacillus Anthracis Strain V770-np1-r Antigens
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
Intramuscular - Administration within a muscle.
Active Ingredient(s)
BACILLUS ANTHRACIS STRAIN V770-NP1-R ANTIGENS 100 ug/mL
Pharmacologic Class
Usage Information
CYFENDUS (Anthrax Vaccine Adsorbed, Adjuvanted) is a vaccine indicated for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. The efficacy of CYFENDUS for post-exposure prophylaxis (PEP) is based solely on studies in animal models of inhalational anthrax.

Regulatory & Marketing

Labeler Name
Emergent Product Development Gaithersburg Inc.
Product Type
Vaccine
FDA Application #
BLA125761
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-19-2023
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 71665-001-02 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 5 ml in 1 vial, multi-dose (71665-001-01) of Cyfendus, a vaccine label labeled by Emergent Product Development Gaithersburg Inc.. This injection, suspension is formulated for intramuscular use and contains bacillus anthracis strain v770-np1-r antigens 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 Emergent Product Development Gaithersburg Inc. on September 19, 2023. The current certification is valid through December 31, 2027.

How is this Emergent Product Development Gaithersburg Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71665000102. 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)
71665-001-02
11-Digit CMS (5-4-2)
71665-0001-02

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