Clopidogrel Tablet, Film Coated
NDC Package 65862-357-99

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

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 Aurobindo Pharma Limited, this product is identified by NDC 65862-357 and is authorized under FDA application ANDA090540.

Identification & Billing

NDC Package Code
65862-357-99
Package Description
1000 TABLET, FILM COATED in 1 BOTTLE
Product Code
65862-357
11-Digit Billing Format
65862035799
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1000 EA
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)
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
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA090540
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-17-2012
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65862-357). Click a package code to view its specific billing and regulatory data.

65862-357-01
100 TABLET, FILM COATED in 1 BOTTLE
65862-357-05
500 TABLET, FILM COATED in 1 BOTTLE
65862-357-10
10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK
65862-357-30
30 TABLET, FILM COATED in 1 BOTTLE
65862-357-61
6000 TABLET, FILM COATED in 1 BAG
65862-357-90
90 TABLET, FILM COATED in 1 BOTTLE

* 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 65862-357-99 identifies a specific commercial package of 1000 tablet, film coated in 1 bottle of Clopidogrel, a human prescription drug labeled by Aurobindo Pharma Limited. 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 Aurobindo Pharma Limited on May 17, 2012. The current certification is valid through December 31, 2026.

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 Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862035799. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1000 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)
65862-357-99
11-Digit CMS (5-4-2)
65862-0357-99

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