Fagus Grandifolia Pollen Injection, Solution
NDC Package 0268-6607-06

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

Package Information

Fagus Grandifolia Pollen (beech) injection is these products are for diagnostic use only. This formulation utilizes a injection, solution delivery system. Marketed by Alk-abello, Inc., this product is identified by NDC 0268-6607 and is authorized under FDA application BLA103753.

Identification & Billing

NDC Package Code
0268-6607-06
Package Description
5 mL in 1 VIAL, MULTI-DOSE
Product Code
0268-6607
11-Digit Billing Format
00268660706
RxNorm Crosswalk
  • RxCUI: 1013964 - bald cypress pollen extract 50 MG/ML Injectable Solution
  • RxCUI: 1013964 - bald cypress pollen extract 0.05 GM/ML Injectable Solution
  • RxCUI: 1013964 - Taxodium distichum pollen extract 0.05 GM/ML Injectable Solution
  • RxCUI: 1013964 - Taxodium distichum pollen extract 50 MG/ML Injectable Solution
  • RxCUI: 1014194 - cedar elm pollen extract 50 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Fagus Grandifolia Pollen
Non-Proprietary Name
Beech
Substance Name
Fagus Grandifolia 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
Percutaneous - Administration through the skin.
Active Ingredient(s)
FAGUS GRANDIFOLIA POLLEN .05 g/mL
Pharmacologic Class
Usage Information
These products are for diagnostic use only. Diagnostic allergenic extracts are indicated for use in skin testing to establish the clinical relevance of specific allergens to which the patient has been exposed. By measuring skin test response the physician may assess the degree of sensitivity that patients have to the allergens. For extracts standardized in AU and BAU, see individual directions for use. Allergenic extracts for diagnostic use only of coffee, mosquito, cottonseed, and flaxseed have not been shown by adequate data to be safe and effective for therapeutic use.

Regulatory & Marketing

Labeler Name
Alk-abello, Inc.
Product Type
Non-standardized Allergenic
FDA Application #
BLA103753
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
01-01-1965
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0268-6607-06 identifies a specific commercial package of 5 ml in 1 vial, multi-dose of Fagus Grandifolia Pollen, a non-standardized allergenic label labeled by Alk-abello, Inc.. This injection, solution is formulated for percutaneous use and contains fagus grandifolia 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 January 01, 1965. 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: 00268660706. 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)
0268-6607-06
11-Digit CMS (5-4-2)
00268-6607-06

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