Aplisol Injection
NDC Package 42023-104-01

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

Aplisol (tuberculin purified protein derivative) injection is tuberculin PPD is indicated as an aid in the detection of infection with Mycobacterium tuberculosis. This formulation utilizes a injection delivery system. Marketed by Endo Usa, Inc., this product is identified by NDC 42023-104 and is authorized under FDA application BLA103782.

Identification & Billing

NDC Package Code
42023-104-01
Package Description
1 VIAL in 1 CARTON / 1 mL in 1 VIAL
Product Code
42023-104
11-Digit Billing Format
42023010401
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: 798408 - Aplisol 5 UNT in 0.1 ML Injectable Solution
  • RxCUI: 798408 - purified protein derivative of tuberculin 50 UNT/ML Injectable Solution [Aplisol]

Clinical Specifications

Proprietary Name
Aplisol
Non-Proprietary Name
Tuberculin Purified Protein Derivative
Substance Name
Tuberculin Purified Protein Derivative
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intradermal - Administration within the dermis.
Active Ingredient(s)
TUBERCULIN PURIFIED PROTEIN DERIVATIVE 5 [iU]/.1mL
Pharmacologic Class
Usage Information
Tuberculin PPD is indicated as an aid in the detection of infection with Mycobacterium tuberculosis. The standard tuberculin test employs the intradermal (Mantoux) test using a 5 TU dose of tuberculin PPD.7 The 0.1 mL test dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 TU dose which has been clinically utilized and standardized with PPD-S. Tuberculin skin testing is not contraindicated for persons who have been vaccinated with BCG and the skin-test results of such persons are used to support or exclude the diagnosis of M. tuberculosis infections.4 HIV infection is a strong risk factor for the development of TB disease in persons having TB infection. All HIV-infected persons should receive a PPD-tuberculin skin test.3

Regulatory & Marketing

Labeler Name
Endo Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA103782
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-25-2008
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42023-104). Click a package code to view its specific billing and regulatory data.

42023-104-05
1 VIAL in 1 CARTON / 5 mL in 1 VIAL

* 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 42023-104-01 identifies a specific commercial package of 1 vial in 1 carton / 1 ml in 1 vial of Aplisol, a human prescription drug labeled by Endo Usa, Inc.. This injection 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 Endo Usa, Inc. on April 25, 2008. The current certification is valid through December 31, 2026.

How is this Endo Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42023010401. 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)
42023-104-01
11-Digit CMS (5-4-2)
42023-0104-01

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