Aplisol
NDC Package 64725-0104-1

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.

Aplisol is tuberculin PPD is indicated as an aid in the detection of infection with. Marketed by Tya Pharmaceuticals, this product is identified by NDC 64725-0104 and is authorized under FDA application BLA103782.

Identification & Billing

NDC Package Code
64725-0104-1
Package Description
5 mL in 1 BOTTLE
Product Code
64725-0104
11-Digit Billing Format
64725010401
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
Dosage Form
-
Usage Information
Tuberculin PPD is indicated as an aid in the detection of infection with . The standard tuberculin test employs the intradermal (Mantoux) test using a 5 TU dose of tuberculin PPD. 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 infections. 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. Mycobacterium tuberculosis7M. tuberculosis43

Regulatory & Marketing

Labeler Name
Tya Pharmaceuticals
FDA Application #
BLA103782
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-25-2014
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 64725-0104-1 identifies a specific commercial package of 5 ml in 1 bottle of Aplisol, labeled by Tya Pharmaceuticals. 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 Tya Pharmaceuticals on April 25, 2014. The current certification is valid through December 31, 2017.

How is this Tya Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64725010401. 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)
64725-0104-1
11-Digit CMS (5-4-2)
64725-0104-01

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