1. Home
  2. Labeler Index
  3. Emergent Product Development Gaithersburg Inc.
  4. 71665-001
  5. NDC Package Code: 71665-001-02 Cyfendus

NDC Package 71665-001-02 Cyfendus

Anthrax Vaccine Adsorbed,Adjuvanted Injection, Suspension Intramuscular - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
71665-001-02
Package Description:
10 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE (71665-001-01)
Product Code:
71665-001
Proprietary Name:
Cyfendus
Non-Proprietary Name:
Anthrax Vaccine Adsorbed, Adjuvanted
Substance Name:
Bacillus Anthracis Strain V770-np1-r Antigens
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.
11-Digit NDC Billing Format:
71665000102
NDC to 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
    • Product Type:
    Vaccine
    Labeler Name:
    Emergent Product Development Gaithersburg Inc.
    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(s):
  • Intramuscular - Administration within a muscle.
    • Active Ingredient(s):
  • BACILLUS ANTHRACIS STRAIN V770-NP1-R ANTIGENS 100 ug/mL
    • Pharmacologic Class(es):
  • Actively Acquired Immunity - [PE] (Physiologic Effect)
  • Anthrax Vaccines - [Chemical/Ingredient]
  • Live Attenuated Bacillus Anthracis Vaccine - [EPC] (Established Pharmacologic Class)
  • Vaccines, Attenuated - [Chemical/Ingredient]
    • Sample Package:
    No
    FDA Application Number:
    BLA125761
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    09-19-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 71665-001-02?

    The NDC Packaged Code 71665-001-02 is assigned to a package of 10 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.. The product's dosage form is injection, suspension and is administered via intramuscular form.

    Is NDC 71665-001 included in the NDC Directory?

    Yes, Cyfendus with product code 71665-001 is active and included in the NDC Directory. The product was first marketed by Emergent Product Development Gaithersburg Inc. on September 19, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 71665-001-02?

    The 11-digit format is 71665000102. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-271665-001-025-4-271665-0001-02