Prasugrel Tablet, Film Coated
NDC Package 43817-239-01

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

Package Information

Prasugrel tablets is prasugrel tablet 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 tablet has been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke compared to clopidogrel. This formulation utilizes a tablet, film coated delivery system. Marketed by Panacea Biotec Limited, this product is identified by NDC 43817-239 and is authorized under FDA application ANDA205897.

Identification & Billing

NDC Package Code
43817-239-01
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
43817-239
11-Digit Billing Format
43817023901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prasugrel
Non-Proprietary Name
Prasugrel
Substance Name
Prasugrel Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PRASUGREL HYDROCHLORIDE 5 mg/1
Pharmacologic Class
Usage Information
Prasugrel tablet 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 tablet 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
Panacea Biotec Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA205897
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-16-2017
End Marketing Date
02-28-2027
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 43817-239-01 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Prasugrel, a human prescription drug labeled by Panacea Biotec Limited. This tablet, film coated is formulated for oral use and contains prasugrel 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 Panacea Biotec Limited on October 16, 2017.

How is this Panacea Biotec Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43817023901. 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)
43817-239-01
11-Digit CMS (5-4-2)
43817-0239-01

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