Sotalol Hydrochloride Injection
NDC Package 69724-112-10

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

Package Information

Sotalol Hydrochloride injection is sotalol hydrochloride is contraindicated in patients with:Sinus bradycardia (<50 bpm), sick sinus syndrome or second or third degree AV block without a pacemakerCongenital or acquired long QT syndromes, QT interval >450 msCardiogenic shock, decompensated heart failureSerum potassium <4 mEq/LBronchial asthma or related bronchospastic conditionsKnown hypersensitivity to sotalol. This formulation utilizes a injection delivery system. Marketed by Altathera Pharmaceuticals, Llc, this product is identified by NDC 69724-112 and is authorized under FDA application NDA022306.

Identification & Billing

NDC Package Code
69724-112-10
Package Description
1 VIAL in 1 CARTON / 10 mL in 1 VIAL
Product Code
69724-112
11-Digit Billing Format
69724011210
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sotalol Hydrochloride
Non-Proprietary Name
Sotalol Hydrochloride
Substance Name
Sotalol Hydrochloride
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
SOTALOL HYDROCHLORIDE 15 mg/mL
Pharmacologic Class
Usage Information
Sotalol hydrochloride is contraindicated in patients with:Sinus bradycardia (<50 bpm), sick sinus syndrome or second or third degree AV block without a pacemakerCongenital or acquired long QT syndromes, QT interval >450 msCardiogenic shock, decompensated heart failureSerum potassium <4 mEq/LBronchial asthma or related bronchospastic conditionsKnown hypersensitivity to sotalol

Regulatory & Marketing

Labeler Name
Altathera Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA022306
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-15-2015
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

C9482
Source: OPPS
Sotalol hydrochloride iv
HCPCS Dosage 1 MG
Units / Pkg 150

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 69724-112-10 identifies a specific commercial package of 1 vial in 1 carton / 10 ml in 1 vial of Sotalol Hydrochloride, a human prescription drug labeled by Altathera Pharmaceuticals, Llc. This injection is formulated for intravenous use and contains sotalol 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 Altathera Pharmaceuticals, Llc on October 15, 2015. The current certification is valid through December 31, 2026.

How is this Altathera Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69724011210. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
69724-112-10
11-Digit CMS (5-4-2)
69724-0112-10

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