Clopidogrel Bisulfate
NDC Package 70400-101-10

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Clopidogrel Bisulfate is • Clopidogrel is indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non–ST-segment elevation ACS (unstable angina [UA]/ non–ST -elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. Marketed by Sterisyn Inc., this product is identified by NDC 70400-101 and is authorized under FDA application ANDA204165.

Identification & Billing

NDC Package Code
70400-101-10
Package Description
1000 TABLET, FILM COATED in 1 BOTTLE
Product Code
70400-101
11-Digit Billing Format
70400010110
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clopidogrel Bisulfate
Dosage Form
-
Usage Information
• Clopidogrel is indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non–ST-segment elevation ACS (unstable angina [UA]/ non–ST -elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. Clopidogrel should be administered in conjunction with aspirin. • Clopidogrel is indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopdiogrel should be administered in conjunction with aspirin.

Regulatory & Marketing

Labeler Name
Sterisyn Inc.
FDA Application #
ANDA204165
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-01-2018
Listing Expiration
12-31-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70400-101). Click a package code to view its specific billing and regulatory data.

70400-101-30
30 TABLET, FILM COATED in 1 BOTTLE
70400-101-90
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 70400-101-10 identifies a specific commercial package of 1000 tablet, film coated in 1 bottle of Clopidogrel Bisulfate, labeled by Sterisyn Inc.. 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 Sterisyn Inc. on March 01, 2018. The current certification is valid through December 31, 2019.

How is this Sterisyn Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70400010110. 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)
70400-101-10
11-Digit CMS (5-4-2)
70400-0101-10

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