Mix Of 7 Standardized Grass Pollen Injection, Solution
NDC Package 0268-8076-06

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

Mix Of 7 Standardized Grass Pollen (agrostis gigantea pollen, dactylis glomerata pollen, festuca pratensis, lolium perenne pollen, phleum pratense pollen, poa pratensis pollen and anthoxanthum odoratum pollen) injection is 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. This formulation utilizes a injection, solution delivery system. Marketed by Alk-abello, Inc., this product is identified by NDC 0268-8076 and is authorized under FDA application BLA103058.

Identification & Billing

NDC Package Code
0268-8076-06
Package Description
5.5 mL in 1 VIAL
Product Code
0268-8076
11-Digit Billing Format
00268807606

Clinical Specifications

Proprietary Name
Mix Of 7 Standardized Grass Pollen
Non-Proprietary Name
Agrostis Gigantea Pollen, Dactylis Glomerata Pollen, Festuca Pratensis, Lolium Perenne Pollen, Phleum Pratense Pollen, Poa Pratensis Pollen And Anthoxanthum Odoratum Pollen
Substance Name
Agrostis Gigantea Pollen; Anthoxanthum Odoratum Pollen; Dactylis Glomerata Pollen; Festuca Pratensis Pollen; Lolium Perenne Pollen; Phleum Pratense Pollen; Poa Pratensis Pollen
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
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Alk-abello, Inc.
Product Type
Standardized Allergenic
FDA Application #
BLA103058
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-18-1997
Listing Expiration
12-31-2026
Exclude Flag
N
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 (0268-8076). Click a package code to view its specific billing and regulatory data.

0268-8076-10
10.5 mL in 1 VIAL
0268-8076-50
53 mL in 1 VIAL

* 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 0268-8076-06 identifies a specific commercial package of 5.5 ml in 1 vial of Mix Of 7 Standardized Grass Pollen, a standardized allergenic label labeled by Alk-abello, Inc.. This injection, solution is formulated for subcutaneous use and contains agrostis gigantea pollen; anthoxanthum odoratum pollen; dactylis glomerata pollen; festuca pratensis pollen; lolium perenne pollen; phleum pratense pollen; poa pratensis pollen as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Alk-abello, Inc. on December 18, 1997. The current certification is valid through December 31, 2026.

How is this Alk-abello, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00268807606. 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 (4-4-2)
0268-8076-06
11-Digit CMS (5-4-2)
00268-8076-06

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