NDC Package 65044-2297-1 Pollens - Weeds And Garden Plants, Short Ragweed, Ambrosia Artemisiifolia

Short Ragweed,Ambrosia Artemisiifolia Injection, Solution Percutaneous; Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Package Information

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:
65044-2297-1
Package Description:
5 mL in 1 VIAL
Product Code:
Proprietary Name:
Pollens - Weeds And Garden Plants, Short Ragweed, Ambrosia Artemisiifolia
Non-Proprietary Name:
Short Ragweed, Ambrosia Artemisiifolia
Substance Name:
Ambrosia Artemisiifolia Pollen
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.
11-Digit NDC Billing Format:
65044229701
NDC to 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
  • Product Type:
    Standardized Allergenic
    Labeler Name:
    Jubilant Hollisterstier Llc
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Percutaneous - Administration through the skin.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Sample Package:
    No
    FDA Application Number:
    BLA103880
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    10-18-1977
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N

    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 CodePackage Description
    65044-2297-210 mL in 1 VIAL
    65044-2297-450 mL in 1 VIAL

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65044-2297-1?

    The NDC Packaged Code 65044-2297-1 is assigned to a package of 5 ml in 1 vial of Pollens - Weeds And Garden Plants, Short Ragweed, Ambrosia Artemisiifolia, a standardized allergenic label labeled by Jubilant Hollisterstier Llc. The product's dosage form is injection, solution and is administered via percutaneous; subcutaneous form.

    Is NDC 65044-2297 included in the NDC Directory?

    Yes, Pollens - Weeds And Garden Plants, Short Ragweed, Ambrosia Artemisiifolia with product code 65044-2297 is active and included in the NDC Directory. The product was first marketed by Jubilant Hollisterstier Llc on October 18, 1977 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 65044-2297-1?

    The 11-digit format is 65044229701. 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 5-4-1 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-165044-2297-15-4-265044-2297-01