Biothrax Injection, Suspension
NDC Package 64678-211-01

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

Package Information

Biothrax (anthrax vaccine adsorbed) injection is bioThrax is a vaccine indicated for the active immunization for the prevention of disease caused by Bacillus anthracis in persons 18 through 65 years of age. This formulation utilizes a injection, suspension delivery system. Marketed by Emergent Biodefense Operations Lansing, Llc, this product is identified by NDC 64678-211 and is authorized under FDA application BLA103821.

Identification & Billing

NDC Package Code
64678-211-01
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE (64678-211-05)
Product Code
64678-211
11-Digit Billing Format
64678021101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • 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
  • RxCUI: 832682 - Biothrax 0.1 MG/mL Injectable Suspension
  • RxCUI: 832682 - Bacillus anthracis strain V770-NP1-R antigens 0.1 MG/ML Injectable Suspension [Biothrax]
  • RxCUI: 832682 - Biothrax 0.1 MG/ML Injectable Suspension

Clinical Specifications

Proprietary Name
Biothrax
Non-Proprietary Name
Anthrax Vaccine Adsorbed
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.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
BACILLUS ANTHRACIS STRAIN V770-NP1-R ANTIGENS 100 ug/mL
Pharmacologic Class
Usage Information
BioThrax is a vaccine indicated for the active immunization for the prevention of disease caused by Bacillus anthracis in persons 18 through 65 years of age.

Regulatory & Marketing

Labeler Name
Emergent Biodefense Operations Lansing, Llc
Product Type
Vaccine
FDA Application #
BLA103821
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-04-1970
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 64678-211-01 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 5 ml in 1 vial, multi-dose (64678-211-05) of Biothrax, a vaccine label labeled by Emergent Biodefense Operations Lansing, Llc. This injection, suspension is formulated for intramuscular; subcutaneous 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 Biodefense Operations Lansing, Llc on November 04, 1970. The current certification is valid through December 31, 2027.

How is this Emergent Biodefense Operations Lansing, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64678021101. 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)
64678-211-01
11-Digit CMS (5-4-2)
64678-0211-01

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