Wheat Smut
NDC Package 49288-0607-3

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.

Wheat Smut is allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Marketed by Antigen Laboratories, Inc., this product is identified by NDC 49288-0607 and is authorized under FDA application BLA102223.

Identification & Billing

NDC Package Code
49288-0607-3
Package Description
10 mL in 1 VIAL, MULTI-DOSE
Product Code
49288-0607
11-Digit Billing Format
49288060703
RxNorm Crosswalk
  • RxCUI: 1006282 - Apiospora montagnei allergenic extract 50 MG/ML Injectable Solution
  • RxCUI: 1006282 - Apiospora montagnei allergenic extract 0.05 GM/ML Injectable Solution
  • RxCUI: 1006288 - Aspergillus flavus allergenic extract 50 MG/ML Injectable Solution
  • RxCUI: 1006288 - Aspergillus flavus allergenic extract 0.05 GM/ML Injectable Solution
  • RxCUI: 1006300 - Aspergillus niger var. niger allergenic extract 50 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Wheat Smut
Dosage Form
-
Usage Information
Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product 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
Antigen Laboratories, Inc.
FDA Application #
BLA102223
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-09-1997
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 (49288-0607). Click a package code to view its specific billing and regulatory data.

49288-0607-1
2 mL in 1 VIAL, MULTI-DOSE
49288-0607-2
5 mL in 1 VIAL, MULTI-DOSE
49288-0607-4
30 mL in 1 VIAL, MULTI-DOSE
49288-0607-5
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 49288-0607-3 identifies a specific commercial package of 10 ml in 1 vial, multi-dose of Wheat Smut, 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 September 09, 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: 49288060703. 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)
49288-0607-3
11-Digit CMS (5-4-2)
49288-0607-03

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