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  5. NDC Package Code: 52709-1701-3 Odactra

NDC Package 52709-1701-3 Odactra

Dermatophagoides Pteronyssinus And Dermatophagoides Farinae Tablet Sublingual - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Odactra
Non-Proprietary Name:
Dermatophagoides Pteronyssinus And Dermatophagoides Farinae
Substance Name:
Dermatophagoides Farinae; Dermatophagoides Pteronyssinus
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.
11-Digit NDC Billing Format:
52709170103
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
3 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1998624 - D. farinae extract 6 SQ-HDM / D. pteronyssinus extract 6 SQ-HDM Sublingual Tablet
  • RxCUI: 1998624 - American house dust mite allergenic extract 6 SQ-HDM / European house dust mite allergenic extract 6 SQ-HDM Sublingual Tablet
  • RxCUI: 1998624 - Dermatophagoides farinae extract 6 SQ-HDM / Dermatophagoides pteronyssinus extract 6 SQ-HDM Sublingual Tablet
  • RxCUI: 1998631 - ODACTRA 12 SQ-HDM Sublingual Tablet
  • RxCUI: 1998631 - American house dust mite allergenic extract 6 SQ-HDM / European house dust mite allergenic extract 6 SQ-HDM Sublingual Tablet [Odactra]
    • Product Type:
    Standardized Allergenic
    Labeler Name:
    Alk-abello A S
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Sublingual - Administration beneath the tongue.
    • Active Ingredient(s):
  • DERMATOPHAGOIDES FARINAE 6 [arb'U]/1
  • DERMATOPHAGOIDES PTERONYSSINUS 6 [arb'U]/1
    • Pharmacologic Class(es):
  • Allergens - [CS]
  • Allergens - [CS]
  • Antigens, Dermatophagoides - [CS]
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Increased IgG Production - [PE] (Physiologic Effect)
  • Insect Proteins - [CS]
  • Standardized Insect Allergenic Extract - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    BLA125592
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    01-01-2018
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    52709-1701-51 BLISTER PACK in 1 CARTON / 5 TABLET in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 52709-1701-3?

    The NDC Packaged Code 52709-1701-3 is assigned to a 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. The product's dosage form is tablet and is administered via sublingual form.

    Is NDC 52709-1701 included in the NDC Directory?

    Yes, Odactra with product code 52709-1701 is active and included in the NDC Directory. The product was first marketed by Alk-abello A S on January 01, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 52709-1701-3?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 3.

    What is the 11-digit format for NDC 52709-1701-3?

    The 11-digit format is 52709170103. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-152709-1701-35-4-252709-1701-03