Standardized Mite D Pteronyssinus
NDC Package 54575-326-10

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Standardized Mite D Pteronyssinus is standardized mite extract is used for the diagnosis and treatment of allergic disease to mite. Marketed by Allergy Laboratories, Inc., this product is identified by NDC 54575-326 and is authorized under FDA application BLA101378.

Identification & Billing

NDC Package Code
54575-326-10
Package Description
10 mL in 1 VIAL, MULTI-DOSE
Product Code
54575-326
11-Digit Billing Format
54575032610
RxNorm Crosswalk
  • RxCUI: 852825 - American house dust mite extract 10000 AU/ML Injectable Solution
  • RxCUI: 852825 - American house dust mite allergenic extract 10000 AU/ML Injectable Solution
  • RxCUI: 852825 - Dermatophagoides farinae extract 10,000 AU/ML Injectable Solution
  • RxCUI: 852829 - European house dust mite extract 10000 AU/ML Injectable Solution
  • RxCUI: 852829 - European house dust mite allergenic extract 10000 AU/ML Injectable Solution

Clinical Specifications

Proprietary Name
Standardized Mite D Pteronyssinus
Dosage Form
-
Usage Information
Standardized mite extract is used for the diagnosis and treatment of allergic disease to mite. Diagnosis of allergic disease to mite is made through a combined medical history sufficiently complete to identify allergic symptoms to mite and identification of mite allergy by diagnostic skin testing.Hyposensitization therapy to mite is treatment for patients exhibiting allergic reactions to mite. Immunotherapy is intended for patients whose symptoms cannot be satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. (5)

Regulatory & Marketing

Labeler Name
Allergy Laboratories, Inc.
FDA Application #
BLA101378
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-11-1991
End Marketing Date
02-22-2023
Listing Expiration
02-22-2023
Exclude Flag
D
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 (54575-326). Click a package code to view its specific billing and regulatory data.

54575-326-02
2 mL in 1 VIAL, MULTI-DOSE
54575-326-30
30 mL in 1 VIAL, MULTI-DOSE
54575-326-50
50 mL in 1 VIAL, MULTI-DOSE

* 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 54575-326-10 identifies a specific commercial package of 10 ml in 1 vial, multi-dose of Standardized Mite D Pteronyssinus, labeled by Allergy 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 Allergy Laboratories, Inc. on December 11, 1991. The current certification is valid through February 22, 2023.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54575032610. 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)
54575-326-10
11-Digit CMS (5-4-2)
54575-0326-10

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