Diluent For Acam2000 Solution
NDC Package 71665-340-03

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

Package Information

Diluent For Acam2000 (diluent for smallpox and mpox (vaccinia) vaccine, live) solution 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 solution delivery system. Marketed by Emergent Product Development Gaithersburg Inc., this product is identified by NDC 71665-340 and is authorized under FDA application BLA125158.

Identification & Billing

NDC Package Code
71665-340-03
Package Description
8 CARTON in 1 CASE / 50 VIAL, GLASS in 1 CARTON (71665-340-02) / .6 mL in 1 VIAL, GLASS (71665-340-01)
Product Code
71665-340
11-Digit Billing Format
71665034003
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
Diluent For Acam2000
Non-Proprietary Name
Diluent For Smallpox And Mpox (vaccinia) Vaccine, Live
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Percutaneous - Administration through the skin.
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 71665-340-03 identifies a specific commercial package of 8 carton in 1 case / 50 vial, glass in 1 carton (71665-340-02) / .6 ml in 1 vial, glass (71665-340-01) of Diluent For Acam2000, a vaccine label labeled by Emergent Product Development Gaithersburg Inc.. This solution is formulated for percutaneous 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 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: 71665034003. 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)
71665-340-03
11-Digit CMS (5-4-2)
71665-0340-03

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