Prasugrel Tablet, Film Coated
NDC Package 0378-5186-93

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

Package Information

Prasugrel tablets are indicated to reduce the rate of thrombotic 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 have 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 Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-5186 and is authorized under FDA application ANDA205927.

Identification & Billing

NDC Package Code
0378-5186-93
Package Description
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
0378-5186
11-Digit Billing Format
00378518693
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
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 10 mg/1
Pharmacologic Class
Usage Information
Prasugrel tablets are indicated to reduce the rate of thrombotic 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 have 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
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA205927
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-15-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0378-5186-93 identifies a specific commercial package of 30 tablet, film coated in 1 bottle, plastic of Prasugrel, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. 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 Mylan Pharmaceuticals Inc. on August 15, 2017. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378518693. 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 (4-4-2)
0378-5186-93
11-Digit CMS (5-4-2)
00378-5186-93

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