NDC Package 65044-0611-2 Standardized Grass Pollen, Fescue, Meadow

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:
65044-0611-2
Package Description:
10 mL in 1 VIAL
Product Code:
Proprietary Name:
Standardized Grass Pollen, Fescue, Meadow
Non-Proprietary Name:
Standardized Grass Pollen, Fescue, Meadow
Substance Name:
Festuca Pratensis Pollen
Usage Information:
16, 17, 18, 20 Standardized glycerinated allergenic extracts in potencies of 10,000 BAU/mL and 100,000 BAU/mL are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific grass pollens. Concentrated extracts must be diluted prior to use in intradermal testing and immunotherapy. 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. 27, 28 10,000 BAU/mL dose form should be used initially for percutaneous testing. If negative, the 100,000 BAU/mL dose can be used.The use of mixed or 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 allergen. 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. Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products.
11-Digit NDC Billing Format:
65044061102
NDC to 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: 851881 - orchard grass pollen extract 10000 BAU/ML Injectable Solution
  • RxCUI: 851881 - Dactylis glomerata pollen extract 10,000 BAU/ML Injectable Solution
  • RxCUI: 851901 - sweet vernal grass pollen extract 10000 BAU/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:
    BLA103874
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    01-15-1998
    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
    65044-0611-15 mL in 1 VIAL
    65044-0611-330 mL in 1 VIAL
    65044-0611-450 mL in 1 VIAL

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65044-0611-2?

    The NDC Packaged Code 65044-0611-2 is assigned to a package of 10 ml in 1 vial of Standardized Grass Pollen, Fescue, Meadow, 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 65044-0611 included in the NDC Directory?

    Yes, Standardized Grass Pollen, Fescue, Meadow with product code 65044-0611 is active and included in the NDC Directory. The product was first marketed by Jubilant Hollisterstier Llc on January 15, 1998 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 65044-0611-2?

    The 11-digit format is 65044061102. 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
    5-4-165044-0611-25-4-265044-0611-02