Prasugrel
NDC Package 67877-604-30

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 inactivated by the FDA.

Prasugrel is tablets is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI).Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI.Prasugrel tablets has been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke compared to clopidogrel. Marketed by Ascend Laboratories, Llc, this product is identified by NDC 67877-604 and is authorized under FDA application ANDA205790.

Identification & Billing

NDC Package Code
67877-604-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
67877-604
11-Digit Billing Format
67877060430
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prasugrel
Dosage Form
-
Usage Information
Prasugrel tablets is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI).Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI.Prasugrel tablets has been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke compared to clopidogrel. The difference between treatments was driven predominantly by MI, with no difference on strokes and little difference on CV death [see Clinical Studies ( 14)].

Regulatory & Marketing

Labeler Name
Ascend Laboratories, Llc
FDA Application #
ANDA205790
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-17-2017
Listing Expiration
12-31-2022
Exclude Flag
I
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 67877-604-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Prasugrel, labeled by Ascend Laboratories, Llc. 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 Ascend Laboratories, Llc on October 17, 2017. The current certification is valid through December 31, 2022.

How is this Ascend Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67877060430. 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)
67877-604-30
11-Digit CMS (5-4-2)
67877-0604-30

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