NDC Package 24338-530-48 Sotylize

Sotalol Hydrochloride Solution Oral - View Billable Units, 11-Digit Format, RxNorm

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:
24338-530-48
Package Description:
480 mL in 1 BOTTLE
Product Code:
Proprietary Name:
Sotylize
Non-Proprietary Name:
Sotalol Hydrochloride
Substance Name:
Sotalol Hydrochloride
Usage Information:
This medication is used to treat a serious (possibly life-threatening) type of fast heartbeat called sustained ventricular tachycardia. It is also used to treat certain fast/irregular heartbeats (atrial fibrillation/flutter) in patients with severe symptoms such as weakness and shortness of breath. Sotalol helps to lessen these symptoms. It slows the heart rate and helps the heart to beat more normally and regularly. This medication is both a beta blocker and an anti-arrhythmic.
11-Digit NDC Billing Format:
24338053048
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
480 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 1593725 - sotalol HCl 5 MG in 1 mL Oral Solution
  • RxCUI: 1593725 - sotalol hydrochloride 5 MG/ML Oral Solution
  • RxCUI: 1593725 - sotalol HCl 5 MG per 1 ML Oral Solution
  • RxCUI: 1593731 - Sotylize 5 MG in 1 mL Oral Solution
  • RxCUI: 1593731 - sotalol hydrochloride 5 MG/ML Oral Solution [Sotylize]
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Azurity Pharmaceuticals, Inc.
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    NDA205108
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-01-2015
    Listing Expiration Date:
    12-31-2025
    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
    24338-530-25250 mL in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 24338-530-48?

    The NDC Packaged Code 24338-530-48 is assigned to a package of 480 ml in 1 bottle of Sotylize, a human prescription drug labeled by Azurity Pharmaceuticals, Inc.. The product's dosage form is solution and is administered via oral form.This product is billed per "ML" milliliter and contains an estimated amount of 480 billable units per package.

    Is NDC 24338-530 included in the NDC Directory?

    Yes, Sotylize with product code 24338-530 is active and included in the NDC Directory. The product was first marketed by Azurity Pharmaceuticals, Inc. on March 01, 2015 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 24338-530-48?

    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 480.

    What is the 11-digit format for NDC 24338-530-48?

    The 11-digit format is 24338053048. 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
    5-3-224338-530-485-4-224338-0530-48