1. Home
  2. Labeler Index
  3. Bryant Ranch Prepack
  4. 71335-1985
  5. NDC Package Code: 71335-1985-2 Amiodarone Hydrochloride

NDC Package 71335-1985-2 Amiodarone 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:
71335-1985-2
Package Description:
30 TABLET in 1 BOTTLE
Product Code:
71335-1985
Proprietary Name:
Amiodarone Hydrochloride
Non-Proprietary Name:
Amiodarone Hydrochloride
Substance Name:
Amiodarone Hydrochloride
Usage Information:
Amiodarone Hydrochloride Tablets is indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated.
11-Digit NDC Billing Format:
71335198502
NDC to RxNorm Crosswalk:
  • RxCUI: 833528 - amiodarone HCl 200 MG Oral Tablet
  • RxCUI: 833528 - amiodarone hydrochloride 200 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bryant Ranch Prepack
    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):
  • AMIODARONE HYDROCHLORIDE 200 mg/1
    • Pharmacologic Class(es):
  • Antiarrhythmic - [EPC] (Established Pharmacologic Class)
  • Cytochrome P450 1A2 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C9 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 2D6 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A Inhibitors - [MoA] (Mechanism of Action)
  • P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA078578
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-09-2020
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    71335-1985-1200 TABLET in 1 BOTTLE
    71335-1985-360 TABLET in 1 BOTTLE
    71335-1985-490 TABLET in 1 BOTTLE
    71335-1985-510 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 71335-1985-2?

    The NDC Packaged Code 71335-1985-2 is assigned to a package of 30 tablet in 1 bottle of Amiodarone Hydrochloride, a human prescription drug labeled by Bryant Ranch Prepack. The product's dosage form is tablet and is administered via oral form.

    Is NDC 71335-1985 included in the NDC Directory?

    Yes, Amiodarone Hydrochloride with product code 71335-1985 is active and included in the NDC Directory. The product was first marketed by Bryant Ranch Prepack on March 09, 2020 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 71335-1985-2?

    The 11-digit format is 71335198502. 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 5-4-1 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
    5-4-171335-1985-25-4-271335-1985-02