NDC 64725-0104 Aplisol

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
64725-0104
Proprietary Name:
Aplisol
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Tya Pharmaceuticals
Labeler Code:
64725
Start Marketing Date: [9]
04-25-2014
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 64725-0104-1

Package Description: 5 mL in 1 BOTTLE

Product Details

What is NDC 64725-0104?

The NDC code 64725-0104 is assigned by the FDA to the product Aplisol which is product labeled by Tya Pharmaceuticals. The product's dosage form is . The product is distributed in a single package with assigned NDC code 64725-0104-1 5 ml in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Aplisol?

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

Which are Aplisol UNII Codes?

The UNII codes for the active ingredients in this product are:

  • TUBERCULIN PURIFIED PROTEIN DERIVATIVE (UNII: I7L8FKN87J)
  • TUBERCULIN PURIFIED PROTEIN DERIVATIVE (UNII: I7L8FKN87J) (Active Moiety)

Which are Aplisol Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Aplisol?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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]

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".