Acam2000 Injection, Powder, Lyophilized, For Solution
NDC Package 71665-430-03

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

Package Information

Acam2000 (smallpox and mpox (vaccinia) vaccine, live) injection is aCAM2000® is indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Emergent Product Development Gaithersburg Inc., this product is identified by NDC 71665-430 and is authorized under FDA application BLA125158.

Identification & Billing

NDC Package Code
71665-430-03
Package Description
8 CARTON in 1 CASE / 50 VIAL, MULTI-DOSE in 1 CARTON (71665-430-02) / .3 mL in 1 VIAL, MULTI-DOSE (71665-430-01)
Product Code
71665-430
11-Digit Billing Format
71665043003
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 833082 - smallpox (vaccinia) vaccine, live Injectable Solution
  • RxCUI: 833082 - smallpox vaccine live, New York City Board of Health vaccinia strain 500000000 UNT/ML Injectable Solution
  • RxCUI: 833086 - ACAM2000 smallpox (vaccinia) vaccine, live Injectable Solution
  • RxCUI: 833086 - smallpox vaccine live, New York City Board of Health vaccinia strain 500000000 UNT/ML Injectable Solution [ACAM2000]
  • RxCUI: 833086 - ACAM2000 500000000 UNT/ML Injectable Solution

Clinical Specifications

Proprietary Name
Acam2000
Non-Proprietary Name
Smallpox And Mpox (vaccinia) Vaccine, Live
Substance Name
Vaccinia Virus Strain New York City Board Of Health Live Antigen
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Percutaneous - Administration through the skin.
Active Ingredient(s)
VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN 100000000 [PFU]/mL
Pharmacologic Class
Usage Information
ACAM2000® is indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.

Regulatory & Marketing

Labeler Name
Emergent Product Development Gaithersburg Inc.
Product Type
Vaccine
FDA Application #
BLA125158
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-31-2007
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71665-430-03 identifies a specific commercial package of 8 carton in 1 case / 50 vial, multi-dose in 1 carton (71665-430-02) / .3 ml in 1 vial, multi-dose (71665-430-01) of Acam2000, a vaccine label labeled by Emergent Product Development Gaithersburg Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for percutaneous use and contains vaccinia virus strain new york city board of health live 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 Emergent Product Development Gaithersburg Inc. on August 31, 2007. The current certification is valid through December 31, 2026.

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: 71665043003. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
71665-430-03
11-Digit CMS (5-4-2)
71665-0430-03

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