Pollens - Weeds And Garden Plants, Short Ragweed, Ambrosia Artemisiifolia
NDC Package 65044-2298-5

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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

Pollens - Weeds And Garden Plants, Short Ragweed, Ambrosia Artemisiifolia is 20, 21, 22, 23 Allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. Marketed by Jubilant Hollisterstier Llc, this product is identified by NDC 65044-2298 and is authorized under FDA application BLA103880.

Identification & Billing

NDC Package Code
65044-2298-5
Package Description
5 mL in 1 VIAL
Product Code
65044-2298
11-Digit Billing Format
65044229805
RxNorm Crosswalk
  • RxCUI: 896138 - short ragweed pollen extract 50 MG/ML Injectable Solution
  • RxCUI: 896138 - Ambrosia artemisiifolia pollen extract 0.05 GM/ML Injectable Solution
  • RxCUI: 896138 - Ambrosia artemisiifolia pollen extract 50 MG/ML Injectable Solution
  • RxCUI: 896150 - short ragweed pollen extract 500 UNT/ML Injectable Solution
  • RxCUI: 896150 - Ambrosia artemisiifolia pollen extract 500 UNT/ML Injectable Solution

Clinical Specifications

Proprietary Name
Pollens - Weeds And Garden Plants, Short Ragweed, Ambrosia Artemisiifolia
Dosage Form
-
Usage Information
20, 21, 22, 23 Allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing.24, 25The use of mixes of unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction; while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed antigen.Statistically controlled blind studies have demonstrated the effectiveness of therapy with Amb a 1.26 However, double blind studies have demonstrated a greater effectiveness for whole Short Ragweed extract when compared to Amb a 1 alone.27 Short Ragweed Extracts, standardized on the basis of Amb a 1 extract, would seem to be a logical choice for immunotherapy.Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen.

Regulatory & Marketing

Labeler Name
Jubilant Hollisterstier Llc
FDA Application #
BLA103880
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-18-1977
End Marketing Date
03-01-2022
Listing Expiration
03-01-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65044-2298-5 identifies a specific commercial package of 5 ml in 1 vial of Pollens - Weeds And Garden Plants, Short Ragweed, Ambrosia Artemisiifolia, labeled by Jubilant Hollisterstier Llc. 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 Jubilant Hollisterstier Llc on October 18, 1977. The current certification is valid through March 01, 2022.

How is this Jubilant Hollisterstier Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65044229805. 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)
65044-2298-5
11-Digit CMS (5-4-2)
65044-2298-05

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