Effient
NDC Package 65597-601-30

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Effient is prasugrel is used with aspirin by patients with heart disease (recent heart attack, unstable angina) who undergo a certain heart procedure (angioplasty). Marketed by Daiichi Sankyo, Inc., this product is identified by NDC 65597-601 and is authorized under FDA application NDA022307.

Identification & Billing

NDC Package Code
65597-601-30
Package Description
30 TABLET, COATED in 1 BOTTLE
Product Code
65597-601
11-Digit Billing Format
65597060130
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA

Clinical Specifications

Proprietary Name
Effient
Dosage Form
-
Usage Information
Prasugrel is used with aspirin by patients with heart disease (recent heart attack, unstable angina) who undergo a certain heart procedure (angioplasty). This medication helps to prevent other serious heart/blood vessel problems (such as heart attacks, strokes, blood clots in stents). It works by blocking platelets from sticking together and prevents them from forming harmful blood clots. This "anti-platelet" effect helps to keep blood flowing smoothly in your body.

Regulatory & Marketing

Labeler Name
Daiichi Sankyo, Inc.
FDA Application #
NDA022307
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-10-2009
End Marketing Date
12-31-2023
Listing Expiration
12-31-2023
Exclude Flag
D
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 65597-601-30 identifies a specific commercial package of 30 tablet, coated in 1 bottle of Effient, labeled by Daiichi Sankyo, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Daiichi Sankyo, Inc. on July 10, 2009. The current certification is valid through December 31, 2023.

What are the primary indications for this medication?

Prasugrel is used with aspirin by patients with heart disease (recent heart attack, unstable angina) who undergo a certain heart procedure (angioplasty). This medication helps to prevent other serious heart/blood vessel problems (such as heart attacks, strokes, blood clots in stents). It works by blocking platelets from sticking together and prevents them from forming harmful blood clots. This "anti-platelet" effect helps to keep blood flowing smoothly in your body.

How is this Daiichi Sankyo, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65597060130. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 (5-3-2)
65597-601-30
11-Digit CMS (5-4-2)
65597-0601-30

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