Standardized Short Ragweed Pollen
NDC Package 49288-0448-2

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.

Standardized Short Ragweed Pollen 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 short ragweed pollen.  Confirmation is determined by skin testing. Marketed by Antigen Laboratories, Inc., this product is identified by NDC 49288-0448 and is authorized under FDA application BLA102232.

Identification & Billing

NDC Package Code
49288-0448-2
Package Description
5 mL in 1 VIAL, MULTI-DOSE
Product Code
49288-0448
11-Digit Billing Format
49288044802
RxNorm Crosswalk
  • RxCUI: 896144 - short ragweed pollen extract 100000 AU/ML Injectable Solution
  • RxCUI: 896144 - Ambrosia artemisiifolia pollen extract 100,000 AU/ML Injectable Solution

Clinical Specifications

Proprietary Name
Standardized Short Ragweed Pollen
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 short ragweed pollen.  Confirmation is determined by skin testing.

Regulatory & Marketing

Labeler Name
Antigen Laboratories, Inc.
FDA Application #
BLA102232
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
01-15-1983
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 (49288-0448). Click a package code to view its specific billing and regulatory data.

49288-0448-3
10 mL in 1 VIAL, MULTI-DOSE
49288-0448-4
30 mL in 1 VIAL, MULTI-DOSE
49288-0448-5
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 49288-0448-2 identifies a specific commercial package of 5 ml in 1 vial, multi-dose of Standardized Short Ragweed Pollen, 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 January 15, 1983. 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: 49288044802. 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)
49288-0448-2
11-Digit CMS (5-4-2)
49288-0448-02

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