1. Home
  2. Labeler Index
  3. Alk-abello A S
  4. NDC Product Code: 52709-1701 Odactra

NDC 52709-1701 Odactra

Dermatophagoides Pteronyssinus And Dermatophagoides Farinae Tablet Sublingual - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 52709-1701?
  5. Odactra Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

NDC Product Code:
52709-1701
Proprietary Name:
Odactra
Non-Proprietary Name: [1]
Dermatophagoides Pteronyssinus And Dermatophagoides Farinae
Substance Name: [2]
Dermatophagoides Farinae; Dermatophagoides Pteronyssinus
NDC Directory Status:
Standardized Allergenic
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Sublingual - Administration beneath the tongue.
    • Labeler Name: [5]
    Alk-abello A S
    Labeler Code:
    52709
    Product Label ID:
    71ca220d-78d5-47d4-be84-8d6e844b24b3
    FDA Application Number: [6]
    BLA125592
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    01-01-2018
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - WHITE TO OFF-WHITE)
    Shape:
    ROUND (C48348)
    Size(s):
    12 MM
    Score:
    1

    Product Packages

    NDC Code 52709-1701-3

    Package Description: 3 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK (52709-1701-1)

    Price per Unit: $11.03053 per EA

    NDC Code 52709-1701-5

    Package Description: 1 BLISTER PACK in 1 CARTON / 5 TABLET in 1 BLISTER PACK

    Product Details

    What is NDC 52709-1701?

    The NDC code 52709-1701 is assigned by the FDA to the product Odactra which is a standardized allergenic label product labeled by Alk-abello A S. The generic name of Odactra is dermatophagoides pteronyssinus and dermatophagoides farinae. The product's dosage form is tablet and is administered via sublingual form. The product is distributed in 2 packages with assigned NDC codes 52709-1701-3 3 blister pack in 1 carton / 10 tablet in 1 blister pack (52709-1701-1), 52709-1701-5 1 blister pack in 1 carton / 5 tablet in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Odactra?

          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.

    What are Odactra Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Odactra UNII Codes?

    The UNII codes for the active ingredients in this product are:

    • DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K)
    • DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (Active Moiety)
    • DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q)
    • DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (Active Moiety)

    Which are Odactra Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Odactra?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • 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]

    Which are the Pharmacologic Classes for Odactra?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".