Propafenone Hydrochloride Capsule, Extended Release
NDC Package 68382-522-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Propafenone Hydrochloride capsules is 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. This formulation utilizes a capsule, extended release delivery system. Marketed by Zydus Pharmaceuticals (usa) Inc., this product is identified by NDC 68382-522 and is authorized under FDA application ANDA214184.

Identification & Billing

NDC Package Code
68382-522-05
Package Description
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
68382-522
11-Digit Billing Format
68382052205
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

Clinical Specifications

Proprietary Name
Propafenone Hydrochloride
Non-Proprietary Name
Propafenone Hydrochloride
Substance Name
Propafenone Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PROPAFENONE HYDROCHLORIDE 225 mg/1
Pharmacologic Class
Antiarrhythmic - [EPC] (Established Pharmacologic Class)
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] .

Regulatory & Marketing

Labeler Name
Zydus Pharmaceuticals (usa) Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA214184
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-02-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68382-522). Click a package code to view its specific billing and regulatory data.

68382-522-14
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68382-522-05 identifies a specific commercial package of 500 capsule, extended release in 1 bottle of Propafenone Hydrochloride, a human prescription drug labeled by Zydus Pharmaceuticals (usa) Inc.. This capsule, extended release is formulated for oral use and contains propafenone hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Zydus Pharmaceuticals (usa) Inc. on February 02, 2022. The current certification is valid through December 31, 2026.

How is this Zydus Pharmaceuticals (usa) Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68382052205. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
68382-522-05
11-Digit CMS (5-4-2)
68382-0522-05

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.