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  5. NDC Package Code: 24478-148-01 Onyda Xr

NDC Package 24478-148-01 Onyda Xr

Clonidine Hydrochloride Suspension, Extended Release Oral - 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:
24478-148-01
Package Description:
7 mL in 1 BOTTLE
Product Code:
24478-148
Proprietary Name:
Onyda Xr
Non-Proprietary Name:
Clonidine Hydrochloride
Substance Name:
Clonidine Hydrochloride
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)].
11-Digit NDC Billing Format:
24478014801
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
7 ML
NDC to 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]
Product Type:
Human Prescription Drug
Labeler Name:
Nextwave Pharmaceuticals, Inc
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
CLONIDINE HYDROCHLORIDE .1 mg/mL
Pharmacologic Class(es):
Sample Package:
Yes
FDA Application Number:
NDA217645
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
08-13-2024
Listing Expiration Date:
12-31-2026
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
24478-148-02120 mL in 1 BOTTLE
24478-148-0330 mL in 1 BOTTLE
24478-148-0460 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 24478-148-01?

The NDC Packaged Code 24478-148-01 is assigned to a package of 7 ml in 1 bottle of Onyda Xr, a human prescription drug labeled by Nextwave Pharmaceuticals, Inc. The product's dosage form is suspension, extended release and is administered via oral form.

Is NDC 24478-148 included in the NDC Directory?

Yes, Onyda Xr with product code 24478-148 is active and included in the NDC Directory. The product was first marketed by Nextwave Pharmaceuticals, Inc on August 13, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 24478-148-01?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 7.

What is the 11-digit format for NDC 24478-148-01?

The 11-digit format is 24478014801. 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 5-3-2 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
5-3-224478-148-015-4-224478-0148-01