Clopidogrel Bisulfate
NDC Package 69117-1010-2

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 1.1 Acute Coronary Syndrome (ACS) 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 Yiling Pharmaceutical,inc., this product is identified by NDC 69117-1010 and is authorized under FDA application ANDA204165.

Identification & Billing

NDC Package Code
69117-1010-2
Package Description
90 TABLET, FILM COATED in 1 BOTTLE
Product Code
69117-1010
11-Digit Billing Format
69117101002
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clopidogrel Bisulfate
Dosage Form
-
Usage Information
1.1 Acute Coronary Syndrome (ACS) 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.1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopdigorel is indicated to reduce the rate of MI and stroke.

Regulatory & Marketing

Labeler Name
Yiling Pharmaceutical,inc.
FDA Application #
ANDA204165
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-05-2017
Listing Expiration
12-31-2021
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 (69117-1010). Click a package code to view its specific billing and regulatory data.

69117-1010-1
30 TABLET, FILM COATED in 1 BOTTLE
69117-1010-3
500 TABLET, FILM COATED in 1 BOTTLE
69117-1010-4
1000 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 69117-1010-2 identifies a specific commercial package of 90 tablet, film coated in 1 bottle of Clopidogrel Bisulfate, labeled by Yiling Pharmaceutical,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 Yiling Pharmaceutical,inc. on May 05, 2017. The current certification is valid through December 31, 2021.

How is this Yiling Pharmaceutical,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69117101002. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 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 (5-4-1)
69117-1010-2
11-Digit CMS (5-4-2)
69117-1010-02

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