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  5. NDC Package Code: 59617-0015-3 Oralair 300 Ir

NDC Package 59617-0015-3 Oralair 300 Ir

Anthoxanthum Odoratum Pollen,Dactylis Glomerata Pollen,Lolium Perenne Pollen,Phleum - 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:
59617-0015-3
Package Description:
1 BLISTER PACK in 1 BOX / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Product Code:
59617-0015
Proprietary Name:
Oralair 300 Ir
Non-Proprietary Name:
Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phleum Pratense Pollen, And Poa Pratensis Pollen
Substance Name:
Anthoxanthum Odoratum Pollen; Dactylis Glomerata Pollen; Lolium Perenne Pollen; Phleum Pratense Pollen; Poa Pratensis Pollen
Usage Information:
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.
11-Digit NDC Billing Format:
59617001503
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • 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
    • Product Type:
    Standardized Allergenic
    Labeler Name:
    Stallergenes
    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):
  • Sublingual - Administration beneath the tongue.
    • Active Ingredient(s):
  • ANTHOXANTHUM ODORATUM POLLEN 300 [IR]/1
  • DACTYLIS GLOMERATA POLLEN 300 [IR]/1
  • LOLIUM PERENNE POLLEN 300 [IR]/1
  • PHLEUM PRATENSE POLLEN 300 [IR]/1
  • POA PRATENSIS POLLEN 300 [IR]/1
    • Pharmacologic Class(es):
  • Allergens - [CS]
  • Allergens - [CS]
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Increased IgG Production - [PE] (Physiologic Effect)
  • Pollen - [CS]
  • Standardized Pollen Allergenic Extract - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    BLA125471
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    04-30-2014
    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
    59617-0015-230 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 59617-0015-3?

    The NDC Packaged Code 59617-0015-3 is assigned to a package of 1 blister pack in 1 box / 3 tablet, orally disintegrating in 1 blister pack of Oralair 300 Ir, a standardized allergenic label labeled by Stallergenes. The product's dosage form is tablet, orally disintegrating and is administered via sublingual form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 59617-0015 included in the NDC Directory?

    Yes, Oralair 300 Ir with product code 59617-0015 is active and included in the NDC Directory. The product was first marketed by Stallergenes on April 30, 2014 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 59617-0015-3?

    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 1.

    What is the 11-digit format for NDC 59617-0015-3?

    The 11-digit format is 59617001503. 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
    5-4-159617-0015-35-4-259617-0015-03