Oralair Tablet, Orally Disintegrating
NDC Package 59617-0010-1
Package Information
Oralair (anthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phleum pratense pollen, and poa pratensis pollen) tablets is a medication used to treat certain allergies that may occur seasonally or year round. This formulation utilizes a tablet, orally disintegrating delivery system. Marketed by Stallergenes, this product is identified by NDC 59617-0010 and is authorized under FDA application BLA125471.
Identification & Billing
- 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
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 59617 - Stallergenes
- 59617-0010 - Oralair
- 59617-0010-1 - 1 BLISTER PACK in 1 BOX / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
- 59617-0010 - Oralair
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 full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 59617-0010-1 identifies a specific commercial package of 1 blister pack in 1 box / 3 tablet, orally disintegrating in 1 blister pack of Oralair 100 Ir, a standardized allergenic label labeled by Stallergenes. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet, orally disintegrating is formulated for sublingual use and contains anthoxanthum odoratum pollen; dactylis glomerata pollen; lolium perenne pollen; phleum pratense pollen; poa pratensis pollen as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Stallergenes on April 30, 2014. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
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.
How is this Stallergenes product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 59617001001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.
