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NDC 59617-0025 Oralair

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

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 59617-0025?
  5. Oralair Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
59617-0025
Proprietary Name:
Oralair
Non-Proprietary Name: [1]
Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phelum Pratense Pollen, And Poa Pratensis Pollen
NDC Directory Status:
Standardized Allergenic
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
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 Structure:
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

Product Packages

NDC Code 59617-0025-1

Package Description: 1 KIT in 1 CARTON * 1 TABLET, ORALLY DISINTEGRATING in 1 BOX * 2 TABLET, ORALLY DISINTEGRATING in 1 BOX

Product Details

What is NDC 59617-0025?

The NDC code 59617-0025 is assigned by the FDA to the product Oralair which is a standardized allergenic label product labeled by Stallergenes. The generic name of Oralair is anthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 59617-0025-1 1 kit in 1 carton * 1 tablet, orally disintegrating in 1 box * 2 tablet, orally disintegrating in 1 box. 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?

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.

Which are Oralair 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 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?

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

* 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.

[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.

[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".