Mixture Of Standardized And Non-standardized Southern Grasses
NDC Package 49288-0239-4

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.

Mixture Of Standardized And Non-standardized Southern Grasses is iNDICATIONS AND USAGE     Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to grass allergens. Marketed by Antigen Laboratories, Inc., this product is identified by NDC 49288-0239 and is authorized under FDA application BLA102226.

Identification & Billing

NDC Package Code
49288-0239-4
Package Description
30 mL in 1 VIAL, MULTI-DOSE
Product Code
49288-0239
11-Digit Billing Format
49288023904
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
Mixture Of Standardized And Non-standardized Southern Grasses
Dosage Form
-
Usage Information
INDICATIONS AND USAGE     Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to grass allergens. Confirmation is determined by skin testing. 10,000 BAU/ml extracts are intended for percutaneous testing. If negative, 100,000 BAU/ml products can be used for percutaneous test. Dilutions made from 10,000 BAU/ml products are indicated for immunotherapy of previously untreated patients. If 10,000 BAU/ml product is tolerated and symptoms persist, dilutions made from 100,000 BAU/ml can be administered. Standardized Grass Pollen extracts labeled in Bioequivalent Allergy Units (BAU/ml) are not interchangeable with grass pollen extracts labeled In Allergy Units (AU/ml) or with non-standardized grass pollen extracts.

Regulatory & Marketing

Labeler Name
Antigen Laboratories, Inc.
FDA Application #
BLA102226
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-13-1997
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (49288-0239). Click a package code to view its specific billing and regulatory data.

49288-0239-3
10 mL in 1 VIAL, MULTI-DOSE
49288-0239-5
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 49288-0239-4 identifies a specific commercial package of 30 ml in 1 vial, multi-dose of Mixture Of Standardized And Non-standardized Southern Grasses, 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 June 13, 1997. 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: 49288023904. 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)
49288-0239-4
11-Digit CMS (5-4-2)
49288-0239-04

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