NDC Package 76385-127-01 Sotalol Hydrochloride AF

Sotalol Hydrochloride Tablets Af Tablet 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:
76385-127-01
Package Description:
100 TABLET in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Sotalol Hydrochloride AF
Non-Proprietary Name:
Sotalol Hydrochloride Tablets Af
Substance Name:
Sotalol Hydrochloride
Usage Information:
Sotalol AF are indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Because Sotalol AF can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB whose AFIB/AFL that is easily reversed (by Valsalva maneuver, for example) should usually not be given Sotalol AF (see WARNINGS).In general, antiarrhythmic therapy for AFIB/AFL aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see Clinical Studies).Sotalol is also indicated for the treatment of documented life-threatening ventricular arrhythmias and is marketed under the brand name Betapace® (sotalol hydrochloride). Sotalol hydrochloride tablets, however, must not be substituted for sotalol hydrochloride tablets (AF) because of significant differences in labeling (i.e., patient package insert, dosing administration and safety information).
11-Digit NDC Billing Format:
76385012701
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1922720 - sotalol HCl AF 120 MG Oral Tablet
  • RxCUI: 1922720 - Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet
  • RxCUI: 1922720 - sotalol hydrochloride AF 120 MG Oral Tablet
  • RxCUI: 1922763 - sotalol HCl AF 160 MG Oral Tablet
  • RxCUI: 1922763 - Atrial Fibrillation sotalol hydrochloride 160 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):
    Sample Package:
    No
    FDA Application Number:
    ANDA207429
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-21-2020
    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
    76385-127-50500 TABLET in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 76385-127-01?

    The NDC Packaged Code 76385-127-01 is assigned to a package of 100 tablet in 1 bottle, plastic of Sotalol Hydrochloride AF, a human prescription drug labeled by Bayshore Pharmaceuticals Llc. The product's dosage form is tablet and is administered via oral form.

    Is NDC 76385-127 included in the NDC Directory?

    Yes, Sotalol Hydrochloride AF with product code 76385-127 is active and included in the NDC Directory. The product was first marketed by Bayshore Pharmaceuticals Llc on February 21, 2020 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 76385-127-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 76385-127-01?

    The 11-digit format is 76385012701. 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
    5-3-276385-127-015-4-276385-0127-01