Clopidogrel Tablet, Film Coated
NDC Package 0615-8014-07

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

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Clopidogrel (clopidogrel bisulfate) tablets is clopidogrel is used to prevent heart attacks and strokes in persons with heart disease (recent heart attack), recent stroke, or blood circulation disease (peripheral vascular disease). This formulation utilizes a tablet, film coated delivery system. Marketed by Ncs Healthcare Of Ky, Llc Dba Vangard Labs, this product is identified by NDC 0615-8014 and is authorized under FDA application ANDA076274.

Identification & Billing

NDC Package Code
0615-8014-07
Package Description
7 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
0615-8014
11-Digit Billing Format
00615801407
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clopidogrel
Non-Proprietary Name
Clopidogrel Bisulfate
Substance Name
Clopidogrel Bisulfate
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)
CLOPIDOGREL BISULFATE 75 mg/1
Pharmacologic Class
Usage Information
Clopidogrel is used to prevent heart attacks and strokes in persons with heart disease (recent heart attack), recent stroke, or blood circulation disease (peripheral vascular disease). It is also used with aspirin to treat new/worsening chest pain (new heart attack, unstable angina) and to keep blood vessels open and prevent blood clots after certain procedures (such as cardiac stent). Clopidogrel works by blocking platelets from sticking together and prevents them from forming harmful clots. It is an antiplatelet drug. It helps keep blood flowing smoothly in your body.

Regulatory & Marketing

Labeler Name
Ncs Healthcare Of Ky, Llc Dba Vangard Labs
Product Type
Human Prescription Drug
FDA Application #
ANDA076274
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-17-2012
End Marketing Date
07-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0615-8014). Click a package code to view its specific billing and regulatory data.

0615-8014-05
15 TABLET, FILM COATED in 1 BLISTER PACK
0615-8014-30
6 BLISTER PACK in 1 BOX, UNIT-DOSE / 5 TABLET, FILM COATED in 1 BLISTER PACK
0615-8014-39
30 TABLET, FILM COATED in 1 BLISTER PACK

* 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 0615-8014-07 identifies a specific commercial package of 7 tablet, film coated in 1 blister pack of Clopidogrel, a human prescription drug labeled by Ncs Healthcare Of Ky, Llc Dba Vangard Labs. This tablet, film coated is formulated for oral use and contains clopidogrel bisulfate 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 Ncs Healthcare Of Ky, Llc Dba Vangard Labs on May 17, 2012.

What are the primary indications for this medication?

Clopidogrel is used to prevent heart attacks and strokes in persons with heart disease (recent heart attack), recent stroke, or blood circulation disease (peripheral vascular disease). It is also used with aspirin to treat new/worsening chest pain (new heart attack, unstable angina) and to keep blood vessels open and prevent blood clots after certain procedures (such as cardiac stent). Clopidogrel works by blocking platelets from sticking together and prevents them from forming harmful clots. It is an antiplatelet drug. It helps keep blood flowing smoothly in your body.

How is this Ncs Healthcare Of Ky, Llc Dba Vangard Labs product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00615801407. 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)
0615-8014-07
11-Digit CMS (5-4-2)
00615-8014-07

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