Disopyramide Phosphate Capsule, Gelatin Coated
NDC Package 59762-0400-1

11-digit billing NDC: 59762040001 · Billing unit: EA · 100 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Disopyramide Phosphate capsules is disopyramide phosphate is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 59762-0400 and is authorized under FDA application NDA017447.

Identification & Billing

NDC Package Code
59762-0400-1
Package Description
100 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code
59762-0400
11-Digit Billing Format
59762040001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Disopyramide Phosphate
Non-Proprietary Name
Disopyramide Phosphate
Substance Name
Disopyramide Phosphate
Dosage Form
Capsule, Gelatin Coated - 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; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DISOPYRAMIDE PHOSPHATE 150 mg/1
Pharmacologic Class
Antiarrhythmic - [EPC] (Established Pharmacologic Class)
Usage Information
Disopyramide phosphate is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of disopyramide phosphate, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.Initiation of disopyramide phosphate treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA017447
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
04-23-2019
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 59762-0400-1 identifies a specific commercial package of 100 capsule, gelatin coated in 1 bottle of Disopyramide Phosphate, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This capsule, gelatin coated is formulated for oral use and contains disopyramide phosphate 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 Mylan Pharmaceuticals Inc. on April 23, 2019. The current certification is valid through December 31, 2027.

How is this Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59762040001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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 (5-4-1)
59762-0400-1
11-Digit CMS (5-4-2)
59762-0400-01

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