Standardized Bermuda Grass Pollen
NDC Package 54575-084-10

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 Bermuda Grass Pollen is       Standardized grass pollen extracts are used for the diagnosis and treatment of allergic disease to grass pollen. Marketed by Allergy Laboratories, Inc., this product is identified by NDC 54575-084 and is authorized under FDA application BLA101379.

Identification & Billing

NDC Package Code
54575-084-10
Package Description
10 mL in 1 VIAL, MULTI-DOSE
Product Code
54575-084
11-Digit Billing Format
54575008410
RxNorm Crosswalk
  • RxCUI: 851873 - redtop grass pollen extract 100000 BAU/ML Injectable Solution
  • RxCUI: 851873 - Agrostis gigantea pollen extract 100,000 BAU/ML Injectable Solution
  • RxCUI: 852157 - Timothy grass pollen extract 100000 BAU/mL Injectable Solution
  • RxCUI: 852157 - Timothy grass pollen extract 100000 BAU/ML Injectable Solution
  • RxCUI: 852157 - Phleum pratense grass pollen extract 100,000 BAU/ML Injectable Solution

Clinical Specifications

Proprietary Name
Standardized Bermuda Grass Pollen
Dosage Form
-
Usage Information
      Standardized grass pollen extracts are used for the diagnosis and treatment of allergic disease to grass pollen. The standardized (Bioequivalent Allergy Unit) extract in these vials is designed primarily for the physician equipped to prepare dilutions and mixtures as required. STANDARDIZED GRASS POLLEN EXTRACTS LABELED IN BAU/ml ARE NOT INTERCHANGEABLE WITH GRASS POLLEN EXTRACTS LABELED IN AU/ml OR WITH NON-STANDARDIZED (WEIGHT/VOLUME) GRASS POLLEN EXTRACTS. Patients being switched from other types of extracts to Allergy Laboratories should have their dose adjusted. Diagnosis of allergic disease to these grasses is made through a combined medical history sufficiently complete to identify allergic symptoms to grass pollen and identification of grass allergy by diagnostic skin testing. It is recommended that diagnostic skin testing (scratch or puncture) be performed with 10,000 BAU/ml grass pollen extracts before testing with 100,000 BAU/ml grass pollen extracts. 10,000 BAU/mL and 100,000 BAU/ml grass pollen extracts for immunotherapy are available for previously treated patients to facilitate dose selection for safe switching from non-standardized to standardized extracts. Patients being treated with grass pollen extracts for the first time can be initially immunized with dilutions prepared from the 10,000 BAU/ml extract (see Dosage and Administration). 100,000 BAU/ml grass pollen extract can be administered if the patient tolerates the 10,000 BAU/ml extract.       Grass pollen immunotherapy is intended for patients whose grass allergic 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 #
BLA101379
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-29-1997
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 (54575-084). Click a package code to view its specific billing and regulatory data.

54575-084-02
2 mL in 1 VIAL, MULTI-DOSE
54575-084-30
30 mL in 1 VIAL, MULTI-DOSE
54575-084-50
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 54575-084-10 identifies a specific commercial package of 10 ml in 1 vial, multi-dose of Standardized Bermuda Grass 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 May 29, 1997. 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: 54575008410. 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)
54575-084-10
11-Digit CMS (5-4-2)
54575-0084-10

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