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  5. NDC Package Code: 13672-056-00 Betapace Af

NDC Package 13672-056-00 Betapace Af

Sotalol Hcl Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
13672-056-00
Package Description:
60 mg in 1 BOTTLE
Product Code:
13672-056
Proprietary Name:
Betapace Af
Non-Proprietary Name:
Sotalol Hcl
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:
13672005600
Product Type:
Human Prescription Drug
Labeler Name:
Skyepharma Production Sas
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 160 mg/160mg
    • 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:
    NDA021151
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    02-22-2000
    Listing Expiration Date:
    12-31-2024
    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.

    Frequently Asked Questions

    What is NDC 13672-056-00?

    The NDC Packaged Code 13672-056-00 is assigned to a package of 60 mg in 1 bottle of Betapace Af, a human prescription drug labeled by Skyepharma Production Sas. The product's dosage form is tablet and is administered via oral form.

    Is NDC 13672-056 included in the NDC Directory?

    Yes, Betapace Af with product code 13672-056 is active and included in the NDC Directory. The product was first marketed by Skyepharma Production Sas on February 22, 2000 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 13672-056-00?

    The 11-digit format is 13672005600. 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
    5-3-213672-056-005-4-213672-0056-00