Onyda Xr Suspension, Extended Release
NDC Package 24478-148-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Onyda Xr (clonidine hydrochloride) suspension is oNYDA XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older [see Clinical Studies (14)]. This formulation utilizes a suspension, extended release delivery system. Marketed by Nextwave Pharmaceuticals, Inc, this product is identified by NDC 24478-148 and is authorized under FDA application NDA217645.

Identification & Billing

NDC Package Code
24478-148-04
Package Description
60 mL in 1 BOTTLE
Product Code
24478-148
11-Digit Billing Format
24478014804
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
60 ML
RxNorm Crosswalk
  • RxCUI: 2690727 - cloNIDine hydrochloride 0.1 MG/mL 24HR Extended Release Suspension
  • RxCUI: 2690727 - 24 HR clonidine hydrochloride 0.1 MG/ML Extended Release Suspension
  • RxCUI: 2690727 - clonidine hydrochloride 0.1 MG/mL 24 HR Extended Release Suspension
  • RxCUI: 2690735 - ONYDA XR 0.1 MG/mL 24HR Extended Release Suspension
  • RxCUI: 2690735 - 24 HR clonidine hydrochloride 0.1 MG/ML Extended Release Suspension [Onyda]

Clinical Specifications

Proprietary Name
Onyda Xr
Non-Proprietary Name
Clonidine Hydrochloride
Substance Name
Clonidine Hydrochloride
Dosage Form
Suspension, Extended Release - A liquid preparation consisting of solid particles dispersed throughout a liquid phase in which the particles are not soluble; the suspension has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form).
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CLONIDINE HYDROCHLORIDE .1 mg/mL
Pharmacologic Class
Usage Information
ONYDA XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older [see Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Nextwave Pharmaceuticals, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA217645
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-13-2024
Listing Expiration
12-31-2026
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 (24478-148). Click a package code to view its specific billing and regulatory data.

24478-148-01
7 mL in 1 BOTTLE
24478-148-02
120 mL in 1 BOTTLE
24478-148-03
30 mL in 1 BOTTLE

* 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 24478-148-04 identifies a specific commercial package of 60 ml in 1 bottle of Onyda Xr, a human prescription drug labeled by Nextwave Pharmaceuticals, Inc. This suspension, extended release is formulated for oral use and contains clonidine 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 Nextwave Pharmaceuticals, Inc on August 13, 2024. The current certification is valid through December 31, 2026.

How is this Nextwave Pharmaceuticals, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 24478014804. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 60 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:

10-Digit Format (5-3-2)
24478-148-04
11-Digit CMS (5-4-2)
24478-0148-04

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