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NDC 59617-0016 Oralair 300 Ir

Anthoxanthum Odoratum Pollen,Dactylis Glomerata Pollen,Lolium Perenne Pollen,Phleum - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 59617-0016?
  5. Oralair 300 Ir 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:
59617-0016
Proprietary Name:
Oralair 300 Ir
Non-Proprietary Name: [1]
Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phleum Pratense Pollen, And Poa Pratensis Pollen
Substance Name: [2]
Anthoxanthum Odoratum Pollen; Dactylis Glomerata Pollen; Lolium Perenne Pollen; Phleum Pratense Pollen; Poa Pratensis Pollen
NDC Directory Status:
Standardized Allergenic
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
Administration Route(s): [4]
  • Sublingual - Administration beneath the tongue.
    • Labeler Name: [5]
    Stallergenes
    Labeler Code:
    59617
    Product Label ID:
    854c9772-63b9-44a3-a11e-77b29c59e91d
    FDA Application Number: [6]
    BLA125471
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    04-30-2014
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - SLIGHTLY SPECKLED WHITE TO BEIGE)
    Shape:
    ROUND (C48348)
    Size(s):
    6 MM
    Imprint(s):
    100
    300
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 59617-0016?

    The NDC code 59617-0016 is assigned by the FDA to the product Oralair 300 Ir which is a standardized allergenic label product labeled by Stallergenes. The generic name of Oralair 300 Ir is anthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phleum pratense pollen, and poa pratensis pollen. The product's dosage form is tablet, orally disintegrating and is administered via sublingual form. The product is distributed in a single package with assigned NDC code 59617-0016-1 1 blister pack in 1 box / 3 tablet, orally disintegrating 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 Oralair 300 Ir?

    This medication is used to treat certain allergies that may occur seasonally or year round. It is an extract of certain plant pollens that can cause allergies. Before prescribing this medication, your doctor must do laboratory/medical tests (such as skin or IgE tests) to learn what you are allergic to. This pollen allergen extract works by making your body less sensitive to the pollens (such as ragweed, grasses) that cause your allergies. This medication will not work right away to relieve allergy symptoms. When taken as directed, it may help relieve symptoms such as sneezing, runny/stuffy nose, cough, or itchy/watery eyes that are caused by allergies.

    What are Oralair 300 Ir 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 Oralair 300 Ir UNII Codes?

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

    • ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y)
    • ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (Active Moiety)
    • DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P)
    • DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P) (Active Moiety)
    • LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0)
    • LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0) (Active Moiety)
    • PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG)
    • PHLEUM PRATENSE TOP (UNII: S7PW24BX20) (Active Moiety)
    • PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (Active Moiety)
    • POA PRATENSIS POLLEN (UNII: SCB8J7LS3T)
    • POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (Active Moiety)

    Which are Oralair 300 Ir 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 Oralair 300 Ir?

    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: 1550700 - Kentucky bluegrass pollen extract 100 IR / orchard grass pollen extract 100 IR / perennial rye grass pollen extract 100 IR / sweet vernal grass pollen extract 100 IR / Timothy grass pollen extract 100 IR Sublingual Tablet
    • RxCUI: 1550700 - Anthoxanthum odoratum grass pollen extract 100 IR / Dactylis glomerata pollen extract 100 IR / Lolium perenne grass pollen extract 100 IR / Phleum pratense grass pollen extract 100 IR / Poa pratensis grass pollen extract 100 IR Sublingual Tablet
    • RxCUI: 1550707 - Oralair 100 IR Sublingual Tablet
    • RxCUI: 1550707 - Kentucky bluegrass pollen extract 100 IR / orchard grass pollen extract 100 IR / perennial rye grass pollen extract 100 IR / sweet vernal grass pollen extract 100 IR / Timothy grass pollen extract 100 IR Sublingual Tablet [Oralair 100]
    • RxCUI: 1550707 - Oralair 100 IR (Anthoxanthum odoratum grass pollen extract 100 IR / Dactylis glomerata pollen extract 100 IR / Lolium perenne grass pollen extract 100 IR / Phleum pratense grass pollen extract 100 IR / Poa pratensis grass pollen extract 100 IR) Sublingual Tablet

    Which are the Pharmacologic Classes for Oralair 300 Ir?

    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".