Clopidogrel Bisulfate Powder
NDC Package 68166-005-01

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Clopidogrel Bisulfate powders 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 powder delivery system. Marketed by Qidong Dongyue Pharmaceutical Co., Ltd., this product is identified by NDC 68166-005.

Identification & Billing

NDC Package Code
68166-005-01
Package Description
25 kg in 1 DRUM
Product Code
68166-005
11-Digit Billing Format
68166000501

Clinical Specifications

Proprietary Name
Clopidogrel Bisulfate
Non-Proprietary Name
Clopidogrel Bisulfate
Substance Name
Clopidogrel Bisulfate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
CLOPIDOGREL BISULFATE 1 kg/kg
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
Qidong Dongyue Pharmaceutical Co., Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
10-30-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 68166-005-01 identifies a specific commercial package of 25 kg in 1 drum of Clopidogrel Bisulfate (UNFINISHED drug), a bulk ingredient labeled by Qidong Dongyue Pharmaceutical Co., Ltd.. This powder is formulated for 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 Qidong Dongyue Pharmaceutical Co., Ltd. on October 30, 2019. 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 Qidong Dongyue Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68166000501. 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)
68166-005-01
11-Digit CMS (5-4-2)
68166-0005-01

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