Odactra Tablet
NDC Package 52709-1701-3

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

Odactra (dermatophagoides pteronyssinus and dermatophagoides farinae) tablets is       ODACTRA™ is an allergen extract indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts. This formulation utilizes a tablet delivery system. Marketed by Alk-abello A S, this product is identified by NDC 52709-1701 and is authorized under FDA application BLA125592.

Identification & Billing

NDC Package Code
52709-1701-3
Package Description
3 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK (52709-1701-1)
Product Code
52709-1701
11-Digit Billing Format
52709170103
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA

Clinical Specifications

Proprietary Name
Odactra
Non-Proprietary Name
Dermatophagoides Pteronyssinus And Dermatophagoides Farinae
Substance Name
Dermatophagoides Farinae; Dermatophagoides Pteronyssinus
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Sublingual - Administration beneath the tongue.
Active Ingredient(s)
Pharmacologic Class
Usage Information
      ODACTRA™ is an allergen extract indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts. ODACTRA is approved for use in adults 18 through 65 years of age.        ODACTRA is not indicated for the immediate relief of allergic symptoms.

Regulatory & Marketing

Labeler Name
Alk-abello A S
Product Type
Standardized Allergenic
FDA Application #
BLA125592
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
01-01-2018
Listing Expiration
12-31-2027
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 (52709-1701). Click a package code to view its specific billing and regulatory data.

52709-1701-5
1 BLISTER PACK in 1 CARTON / 5 TABLET in 1 BLISTER PACK

* 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 52709-1701-3 identifies a specific commercial package of 3 blister pack in 1 carton / 10 tablet in 1 blister pack (52709-1701-1) of Odactra, a standardized allergenic label labeled by Alk-abello A S. This tablet is formulated for sublingual use and contains dermatophagoides farinae; dermatophagoides pteronyssinus 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 A S on January 01, 2018. The current certification is valid through December 31, 2027.

How is this Alk-abello A S product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52709170103. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 total billable units per package. 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 (5-4-1)
52709-1701-3
11-Digit CMS (5-4-2)
52709-1701-03

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