Standardized Mite D. Farinae
NDC Package 0268-0276-30

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Standardized Mite D. Farinae is a medication indicated for the diagnosis and treatment of hypersensitivity in patients with symptoms compatible with dust mite allergy.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. Marketed by Alk-abello, Inc., this product is identified by NDC 0268-0276 and is authorized under FDA application BLA103060.

Identification & Billing

NDC Package Code
0268-0276-30
Package Description
30 mL in 1 VIAL, MULTI-DOSE
Product Code
0268-0276
11-Digit Billing Format
00268027630
RxNorm Crosswalk
  • RxCUI: 1014384 - European house dust mite extract 5000 AU/ML Injectable Solution
  • RxCUI: 1014384 - European house dust mite allergenic extract 5000 AU/ML Injectable Solution
  • RxCUI: 1014384 - Dermatophagoides pteronyssinus extract 5,000 AU/ML Injectable Solution
  • RxCUI: 852813 - American house dust mite extract 5000 AU/ML Injectable Solution
  • RxCUI: 852813 - American house dust mite allergenic extract 5000 AU/ML Injectable Solution

Clinical Specifications

Proprietary Name
Standardized Mite D. Farinae
Dosage Form
-
Usage Information
This product is indicated for the diagnosis and treatment of hypersensitivity in patients with symptoms compatible with dust mite allergy.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. Mixtures of standardized mite (D. farinae and D. pteronyssinus) should be considered for treatment of patients who are sensitive to both species.Prior to the initiation of therapy, 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 be easily avoided.

Regulatory & Marketing

Labeler Name
Alk-abello, Inc.
FDA Application #
BLA103060
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-08-1991
End Marketing Date
08-09-2022
Listing Expiration
08-09-2022
Exclude Flag
D
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 (0268-0276). Click a package code to view its specific billing and regulatory data.

0268-0276-10
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 0268-0276-30 identifies a specific commercial package of 30 ml in 1 vial, multi-dose of Standardized Mite D. Farinae, labeled by Alk-abello, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Alk-abello, Inc. on July 08, 1991. The current certification is valid through August 09, 2022.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00268027630. 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)
0268-0276-30
11-Digit CMS (5-4-2)
00268-0276-30

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