Tubersol
NDC Package 54868-2972-1

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Tubersol is tuberculin Purified Protein Derivative (Mantoux), is indicated to aid diagnosis of tuberculosis infection (TB) in persons at increased risk of developing active disease.The Centers for Disease Control and Prevention (CDC) have published guidelines regarding populations that would benefit from tuberculin skin testing (TST). Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-2972 and is authorized under FDA application BLA103941.

Identification & Billing

NDC Package Code
54868-2972-1
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 1 mL in 1 VIAL, MULTI-DOSE
Product Code
54868-2972
11-Digit Billing Format
54868297201
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 313532 - purified protein derivative of tuberculin 5 UNT in 0.1 ML Injectable Solution
  • RxCUI: 313532 - purified protein derivative of tuberculin 50 UNT/ML Injectable Solution
  • RxCUI: 313532 - purified protein derivative of tuberculin 5 UNT per 0.1 ML Injectable Solution
  • RxCUI: 798415 - TUBERSOL 5 UNT in 0.1 ML Injectable Solution
  • RxCUI: 798415 - purified protein derivative of tuberculin 50 UNT/ML Injectable Solution [Tubersol]

Clinical Specifications

Proprietary Name
Tubersol
Dosage Form
-
Usage Information
TUBERSOL, Tuberculin Purified Protein Derivative (Mantoux), is indicated to aid diagnosis of tuberculosis infection (TB) in persons at increased risk of developing active disease.The Centers for Disease Control and Prevention (CDC) have published guidelines regarding populations that would benefit from tuberculin skin testing (TST). Current recommendations can be accessed at: http://www.cdc.gov/tb/publications/factsheets/testing.htm.Previous BCG vaccination is not a contraindication to tuberculin testing. The skin-test results of BCG vaccinated persons can be used to support or exclude the diagnosis of TB infection. However, an FDA-approved interferon gamma release assay is preferred over tuberculin skin test for persons 5 years of age and older who were previously vaccinated with BCG. (9)

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
BLA103941
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-15-1956
Listing Expiration
12-31-2017
Exclude Flag
I
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 54868-2972-1 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 1 ml in 1 vial, multi-dose of Tubersol, labeled by Physicians Total Care, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Physicians Total Care, Inc. on August 15, 1956. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868297201. 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 (5-4-1)
54868-2972-1
11-Digit CMS (5-4-2)
54868-2972-01

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