Treatment Set Ts331632
NDC Package 49288-0708-3

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.

Treatment Set Ts331632 is when the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Marketed by Antigen Laboratories, Inc., this product is identified by NDC 49288-0708 and is authorized under FDA application BLA102223.

Identification & Billing

NDC Package Code
49288-0708-3
Package Description
10 mL in 1 VIAL, MULTI-DOSE
Product Code
49288-0708
11-Digit Billing Format
49288070803
RxNorm Crosswalk
  • RxCUI: 1191210 - dog hair extract 50 MG/ML / short ragweed pollen extract 800 AU/ML Injectable Solution
  • RxCUI: 1191210 - Ambrosia artemisiifolia pollen extract 800 AU/ML / Canis lupus familiaris hair extract 50 MG/ML Injectable Solution
  • RxCUI: 1192780 - American house dust mite allergenic extract 400 AU/mL / European house dust mite allergenic extract 2000 AU/mL Injectable Solution
  • RxCUI: 1192780 - American house dust mite allergenic extract 400 AU/ML / European house dust mite allergenic extract 2000 AU/ML Injectable Solution
  • RxCUI: 1192780 - American house dust mite extract 400 AU/ML / European house dust mite extract 2000 AU/ML Injectable Solution

Clinical Specifications

Proprietary Name
Treatment Set Ts331632
Dosage Form
-
Usage Information
When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to the cause of a person's allergic condition can be gleaned from a thorough history and careful physical examination. Diagnostic tests - in vitro or in vivo - serve only to confirm the physician's suspicions or to improve investigative skills. Specific diagnosis is especially indicated when the patient's symptoms are not controlled by medication. When immunotherapy is contemplated demonstration of sensitivity to a specific allergenic extract is necessary. An orderly approach to the use of diagnostic tests usually begins with direct skin testing. 5,6,11THIS PRODUCT IS NOT INTENDED FOR TREATMENT OF PATIENTS WHO DO NOT MANIFEST IMMEDIATE HYPERSENSITIVITY REACTIONS TO THE ALLERGENIC EXTRACT FOLLOWING SKIN TESTING.

Regulatory & Marketing

Labeler Name
Antigen Laboratories, Inc.
FDA Application #
BLA102223
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-31-1986
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 49288-0708-3 identifies a specific commercial package of 10 ml in 1 vial, multi-dose of Treatment Set Ts331632, labeled by Antigen Laboratories, 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 Antigen Laboratories, Inc. on October 31, 1986. The current certification is valid through December 31, 2017.

How is this Antigen Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49288070803. 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)
49288-0708-3
11-Digit CMS (5-4-2)
49288-0708-03

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