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  5. NDC Package Code: 76385-114-50 Sotalol

NDC Package 76385-114-50 Sotalol

Sotalol Hydrochloride Tablet 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:
76385-114-50
Package Description:
500 TABLET in 1 BOTTLE, PLASTIC
Product Code:
76385-114
Proprietary Name:
Sotalol
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:
76385011450
NDC to RxNorm Crosswalk:
  • RxCUI: 1923422 - sotalol HCl 120 MG Oral Tablet
  • RxCUI: 1923422 - sotalol hydrochloride 120 MG Oral Tablet
  • RxCUI: 1923424 - sotalol HCl 160 MG Oral Tablet
  • RxCUI: 1923424 - sotalol hydrochloride 160 MG Oral Tablet
  • RxCUI: 1923426 - sotalol HCl 80 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bayshore Pharmaceuticals Llc
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • SOTALOL HYDROCHLORIDE 80 mg/1
    • Pharmacologic Class(es):
  • Adrenergic beta-Antagonists - [MoA] (Mechanism of Action)
  • Antiarrhythmic - [EPC] (Established Pharmacologic Class)
  • Cardiac Rhythm Alteration - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    ANDA207428
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-15-2017
    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
    76385-114-01100 TABLET in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 76385-114-50?

    The NDC Packaged Code 76385-114-50 is assigned to a package of 500 tablet in 1 bottle, plastic of Sotalol, a human prescription drug labeled by Bayshore Pharmaceuticals Llc. The product's dosage form is tablet and is administered via oral form.

    Is NDC 76385-114 included in the NDC Directory?

    Yes, Sotalol with product code 76385-114 is active and included in the NDC Directory. The product was first marketed by Bayshore Pharmaceuticals Llc on December 15, 2017 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 11-digit format for NDC 76385-114-50?

    The 11-digit format is 76385011450. 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
    5-3-276385-114-505-4-276385-0114-50