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  5. NDC Package Code: 0268-3509-06 Standardized Perennial Rye Grass Pollen

NDC Package 0268-3509-06 Standardized Perennial Rye Grass Pollen

Lolium Perenne Pollen Injection, Solution Percutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
0268-3509-06
Package Description:
5 mL in 1 VIAL, MULTI-DOSE
Product Code:
0268-3509
Proprietary Name:
Standardized Perennial Rye Grass Pollen
Non-Proprietary Name:
Lolium Perenne Pollen
Substance Name:
Lolium Perenne Pollen
Usage Information:
Indicated use of allergenic extracts is for the diagnosis and treatment (hyposensitization therapy) of patients who experience allergic symptoms due to exposure to grass pollen and who exhibit type I skin sensitivity when tested to those specific allergens.Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants in situations where the offending allergen cannot be avoided.For previously untreated patients, prior to the initiation of therapy, clinical sensitivity to the standardized grass pollen extract should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.10,000 BAU/mL extracts are indicated for percutaneous testing. If negative, the 100,000 BAU/mL dose may be used. Availability of 10,000 and 100,000 BAU/mL dosages facilitate safe switching. Patients who tolerate dilutions prepared from the 10,000 BAU/mL dosage and require a higher dose may be treated with dilutions prepared from the 100,000 BAU/mL dosage.100,000 BAU/mL concentrations may be especially useful when patients are hyposensitized to numerous allergens. Mixing of allergenic extracts dilutes the potency of each constituent. Using higher concentrations such as 100,000 BAU/mL allows for dilution with other extracts without sacrificing immunizing properties. CAUTION: The final potency of each individual component in a patient mixture should never exceed 10,000 BAU/mL. See also, DOSAGE AND ADMINISTRATION section for discussion of mixture labeling.
11-Digit NDC Billing Format:
00268350906
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:
    Alk-abello, Inc.
    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.
    • Active Ingredient(s):
  • LOLIUM PERENNE POLLEN 100000 [BAU]/mL
    • Pharmacologic Class(es):
  • Allergens - [CS]
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Increased IgG Production - [PE] (Physiologic Effect)
  • Pollen - [CS]
  • Standardized Pollen Allergenic Extract - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    BLA103056
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    12-18-1997
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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.

    Frequently Asked Questions

    What is NDC 0268-3509-06?

    The NDC Packaged Code 0268-3509-06 is assigned to a package of 5 ml in 1 vial, multi-dose of Standardized Perennial Rye Grass Pollen, a standardized allergenic label labeled by Alk-abello, Inc.. The product's dosage form is injection, solution and is administered via percutaneous form.

    Is NDC 0268-3509 included in the NDC Directory?

    Yes, Standardized Perennial Rye Grass Pollen with product code 0268-3509 is active and included in the NDC Directory. The product was first marketed by Alk-abello, Inc. on December 18, 1997 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 0268-3509-06?

    The 11-digit format is 00268350906. 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 4-4-2 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
    4-4-20268-3509-065-4-200268-3509-06