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  5. NDC Package Code: 0093-1061-01 Sotalol Hydrochloride

NDC Package 0093-1061-01 Sotalol Hydrochloride

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:
0093-1061-01
Package Description:
100 TABLET in 1 BOTTLE
Product Code:
0093-1061
Proprietary Name:
Sotalol Hydrochloride
Non-Proprietary Name:
Sotalol Hydrochloride
Substance Name:
Sotalol Hydrochloride
Usage Information:
Sotalol hydrochloride tablets are contraindicated in patients with:•Sinus bradycardia, sick sinus syndrome, second and third degree AV block, unless a functioning pacemaker is present•Congenital or acquired long QT syndromes•Cardiogenic shock or decompensated heart failure•Serum potassium <4 mEq/L•Bronchial asthma or related bronchospastic conditions•Hypersensitivity to sotalolFor the treatment of AFIB/AFL, sotalol hydrochloride tablets are also contraindicated in patients with:•Baseline QT interval >450 ms•Creatinine clearance <40 mL/min
11-Digit NDC Billing Format:
00093106101
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: 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:
    Teva Pharmaceuticals Usa, Inc.
    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:
    ANDA075429
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-04-2000
    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.

    Frequently Asked Questions

    What is NDC 0093-1061-01?

    The NDC Packaged Code 0093-1061-01 is assigned to a package of 100 tablet in 1 bottle of Sotalol Hydrochloride, a human prescription drug labeled by Teva Pharmaceuticals Usa, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 0093-1061 included in the NDC Directory?

    Yes, Sotalol Hydrochloride with product code 0093-1061 is active and included in the NDC Directory. The product was first marketed by Teva Pharmaceuticals Usa, Inc. on May 04, 2000 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 0093-1061-01?

    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 0093-1061-01?

    The 11-digit format is 00093106101. 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 4-4-2 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
    4-4-20093-1061-015-4-200093-1061-01