NDC Package 54575-084-02 Standardized Bermuda Grass Pollen

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

54575-084-02

Package Description:

2 mL in 1 VIAL, MULTI-DOSE

Product Code:

54575-084

Proprietary Name:

Standardized Bermuda Grass Pollen

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)

11-Digit NDC Billing Format:

54575008402

NDC to 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

Labeler Name:

Allergy Laboratories, Inc.

Sample Package:

FDA Application Number:

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 Date:

02-22-2023

Exclude Flag:

Code Structure:

54575 - Allergy Laboratories, Inc.
- 54575-084 - Standardized Bermuda Grass Pollen
  - 54575-084-02 - 2 mL in 1 VIAL, MULTI-DOSE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
54575-084-10	10 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 disclaimer below.

Frequently Asked Questions

What is NDC 54575-084-02?

The NDC Packaged Code 54575-084-02 is assigned to a package of 2 ml in 1 vial, multi-dose of Standardized Bermuda Grass Pollen, labeled by Allergy Laboratories, Inc.. The product's dosage form is and is administered via form.

Is NDC 54575-084 included in the NDC Directory?

No, Standardized Bermuda Grass Pollen with product code 54575-084 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Allergy Laboratories, Inc. on May 29, 1997 and its listing in the NDC Directory is set to expire on February 22, 2023 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 54575-084-02?

The 11-digit format is 54575008402. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	54575-084-02	5-4-2	54575-0084-02

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