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  5. NDC Package Code: 59651-277-05 Propafenone Hydrochloride

NDC Package 59651-277-05 Propafenone Hydrochloride

Capsule, Extended Release 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:
59651-277-05
Package Description:
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code:
59651-277
Proprietary Name:
Propafenone Hydrochloride
Non-Proprietary Name:
Propafenone Hydrochloride
Substance Name:
Propafenone Hydrochloride
Usage Information:
Propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease.Usage Considerations:The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF.Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended.The effect of propafenone on mortality has not been determined [see Boxed Warning].
11-Digit NDC Billing Format:
59651027705
NDC to RxNorm Crosswalk:
  • RxCUI: 861156 - propafenone HCl 225 MG 12HR Extended Release Oral Capsule
  • RxCUI: 861156 - 12 HR propafenone hydrochloride 225 MG Extended Release Oral Capsule
  • RxCUI: 861156 - propafenone hydrochloride 225 MG 12 HR Extended Release Oral Capsule
  • RxCUI: 861164 - propafenone HCl 325 MG 12HR Extended Release Oral Capsule
  • RxCUI: 861164 - 12 HR propafenone hydrochloride 325 MG Extended Release Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aurobindo Pharma Limited
    Dosage Form:
    Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • PROPAFENONE HYDROCHLORIDE 325 mg/1
    • Pharmacologic Class(es):
  • Antiarrhythmic - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA213096
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-21-2023
    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
    59651-277-6060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
    59651-277-9090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 59651-277-05?

    The NDC Packaged Code 59651-277-05 is assigned to a package of 500 capsule, extended release in 1 bottle of Propafenone Hydrochloride, a human prescription drug labeled by Aurobindo Pharma Limited. The product's dosage form is capsule, extended release and is administered via oral form.

    Is NDC 59651-277 included in the NDC Directory?

    Yes, Propafenone Hydrochloride with product code 59651-277 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on February 21, 2023 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 59651-277-05?

    The 11-digit format is 59651027705. 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
    5-3-259651-277-055-4-259651-0277-05