Western Cottonwood Pollen
NDC Package 54575-920-10

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 inactivated by the FDA.

Western Cottonwood Pollen is immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Marketed by Allergy Laboratories, Inc., this product is identified by NDC 54575-920 and is authorized under FDA application BLA101376.

Identification & Billing

NDC Package Code
54575-920-10
Package Description
10 mL in 1 VIAL, MULTI-DOSE
Product Code
54575-920
11-Digit Billing Format
54575092010
RxNorm Crosswalk
  • RxCUI: 1000013 - whole wheat allergenic extract 50 MG/ML Injectable Solution
  • RxCUI: 1000013 - whole wheat allergenic extract 0.05 GM/ML Injectable Solution
  • RxCUI: 1000013 - whole wheat extract 50 MG/ML Injectable Solution
  • RxCUI: 1006300 - Aspergillus niger var. niger allergenic extract 50 MG/ML Injectable Solution
  • RxCUI: 1006300 - Aspergillus niger var. niger allergenic extract 0.05 GM/ML Injectable Solution

Clinical Specifications

Proprietary Name
Western Cottonwood Pollen
Dosage Form
-
Usage Information
Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It 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
Allergy Laboratories, Inc.
FDA Application #
BLA101376
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-07-1967
Listing Expiration
12-31-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54575-920). Click a package code to view its specific billing and regulatory data.

54575-920-02
2 mL in 1 VIAL, MULTI-DOSE
54575-920-30
30 mL in 1 VIAL, MULTI-DOSE
54575-920-50
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 54575-920-10 identifies a specific commercial package of 10 ml in 1 vial, multi-dose of Western Cottonwood Pollen, 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 07, 1967. The current certification is valid through December 31, 2018.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54575092010. 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)
54575-920-10
11-Digit CMS (5-4-2)
54575-0920-10

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