Ryaltris Spray, Metered
NDC Package 59467-700-84

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Ryaltris (olopatadine hydrochloride and mometasone furoate) sprays is rYALTRIS is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older. This formulation utilizes a spray, metered delivery system. Marketed by Hikma Specialty Usa Inc., this product is identified by NDC 59467-700 and is authorized under FDA application NDA211746.

Identification & Billing

NDC Package Code
59467-700-84
Package Description
12 CARTON in 1 BOX / 1 BOTTLE, SPRAY in 1 CARTON / 56 SPRAY, METERED in 1 BOTTLE, SPRAY
Product Code
11-Digit Billing Format
59467070084
RxNorm Crosswalk
  • RxCUI: 2591806 - olopatadine HCL 665 MCG/ACTUAT / mometasone furoate 25 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 2591806 - mometasone furoate 0.025 MG/ACTUAT / olopatadine hydrochloride 0.665 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 2591812 - Ryaltris 665/25 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 2591812 - mometasone furoate 0.025 MG/ACTUAT / olopatadine hydrochloride 0.665 MG/ACTUAT Metered Dose Nasal Spray [Ryaltris]
  • RxCUI: 2591812 - Ryaltris (olopatadine hydrochloride 665 MCG/ACTUAT / mometasone furoate 25 MCG/ACTUAT) Metered Dose Nasal Spray

Clinical Specifications

Proprietary Name
Ryaltris
Non-Proprietary Name
Olopatadine Hydrochloride And Mometasone Furoate
Substance Name
Mometasone Furoate Monohydrate; Olopatadine Hydrochloride
Dosage Form
Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Usage Information
RYALTRIS is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older.

Regulatory & Marketing

Labeler Name
Hikma Specialty Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA211746
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-15-2022
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (59467-700). Click a package code to view its specific billing and regulatory data.

12 CARTON in 1 BOX / 1 BOTTLE, SPRAY in 1 CARTON / 240 SPRAY, METERED in 1 BOTTLE, SPRAY

* 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 59467-700-84 identifies a specific commercial package of 12 carton in 1 box / 1 bottle, spray in 1 carton / 56 spray, metered in 1 bottle, spray of Ryaltris, a human prescription drug labeled by Hikma Specialty Usa Inc.. This spray, metered is formulated for nasal use and contains mometasone furoate monohydrate; olopatadine hydrochloride 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 Hikma Specialty Usa Inc. on August 15, 2022. The current certification is valid through December 31, 2027.

How is this Hikma Specialty Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59467070084. 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:

10-Digit Format (5-3-2)
59467-700-84
11-Digit CMS (5-4-2)
59467-0700-84

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.