Tubersol Injection, Solution
NDC Package 49281-752-22

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

Package Information

Tubersol (tuberculin purified protein derivative) injection is 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). This formulation utilizes a injection, solution delivery system. Marketed by Sanofi Vaccines Us Inc., this product is identified by NDC 49281-752 and is authorized under FDA application BLA103941.

Identification & Billing

NDC Package Code
49281-752-22
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE (49281-752-98)
Product Code
49281-752
11-Digit Billing Format
49281075222
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
Non-Proprietary Name
Tuberculin Purified Protein Derivative
Substance Name
Tuberculin Purified Protein Derivative
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intradermal - Administration within the dermis.
Active Ingredient(s)
TUBERCULIN PURIFIED PROTEIN DERIVATIVE 5 [iU]/.1mL
Pharmacologic Class
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
Sanofi Vaccines Us Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA103941
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-15-1956
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (49281-752). Click a package code to view its specific billing and regulatory data.

49281-752-21
1 VIAL, MULTI-DOSE in 1 CARTON / 1 mL in 1 VIAL, MULTI-DOSE (49281-752-78)

* 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 49281-752-22 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 5 ml in 1 vial, multi-dose (49281-752-98) of Tubersol, a human prescription drug labeled by Sanofi Vaccines Us Inc.. This injection, solution is formulated for intradermal use and contains tuberculin purified protein derivative 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 Sanofi Vaccines Us Inc. on August 15, 1956. The current certification is valid through December 31, 2027.

How is this Sanofi Vaccines Us Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49281075222. 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)
49281-752-22
11-Digit CMS (5-4-2)
49281-0752-22

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