Betula Lenta Pollen Injection, Solution
NDC Package 0268-1069-50

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

Betula Lenta Pollen (birch white) injection is hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided.Prior to initiation of therapy, the clinical sensitivity 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 0268-1069 and is authorized under FDA application BLA103753.

Identification & Billing

NDC Package Code
0268-1069-50
Package Description
50 mL in 1 VIAL, MULTI-DOSE
Product Code
0268-1069
11-Digit Billing Format
00268106950
RxNorm Crosswalk
  • RxCUI: 1000163 - Alternaria alternata allergenic extract 20000 UNT/ML Injectable Solution
  • RxCUI: 1000163 - Alternaria alternata allergenic extract 20,000 UNT/ML Injectable Solution
  • RxCUI: 1000163 - Alternaria tenuis allergenic extract 20,000 UNT/ML Injectable Solution
  • RxCUI: 1006305 - Aspergillus niger var. niger allergenic extract 40000 UNT/ML Injectable Solution
  • RxCUI: 1006305 - Aspergillus niger var. niger allergenic extract 40,000 UNT/ML Injectable Solution

Clinical Specifications

Proprietary Name
Betula Lenta Pollen
Non-Proprietary Name
Birch White
Substance Name
Betula Lenta 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)
BETULA LENTA POLLEN .1 g/mL
Pharmacologic Class
Usage Information
Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided.Prior to initiation of therapy, the clinical sensitivity 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.

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0268-1069). Click a package code to view its specific billing and regulatory data.

0268-1069-10
10 mL in 1 VIAL, MULTI-DOSE

* 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 0268-1069-50 identifies a specific commercial package of 50 ml in 1 vial, multi-dose of Betula Lenta Pollen, a non-standardized allergenic label labeled by Alk-abello, Inc.. This injection, solution is formulated for subcutaneous use and contains betula lenta 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: 00268106950. 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)
0268-1069-50
11-Digit CMS (5-4-2)
00268-1069-50

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