Dabigatran Etexilate Mesylate Powder
NDC Package 14501-0071-2

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.

Dabigatran Etexilate Mesylate powders is dabigatran is used to prevent stroke and harmful blood clots (such as in your legs or lungs) if you have a certain type of irregular heartbeat (atrial fibrillation). This formulation utilizes a powder delivery system. Marketed by Msn Laboratories Private Limited, this product is identified by NDC 14501-0071.

Identification & Billing

NDC Package Code
14501-0071-2
Package Description
50 kg in 1 DRUM
Product Code
14501-0071
11-Digit Billing Format
14501007102

Clinical Specifications

Proprietary Name
Dabigatran Etexilate Mesylate
Non-Proprietary Name
Dabigatran Etexilate Mesylate
Substance Name
Dabigatran Etexilate Mesylate
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)
DABIGATRAN ETEXILATE MESYLATE 1 kg/kg
Usage Information
Dabigatran is used to prevent stroke and harmful blood clots (such as in your legs or lungs) if you have a certain type of irregular heartbeat (atrial fibrillation). Dabigatran is also used to treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) and to reduce the risk of them occurring again. This medication may also be used to prevent these blood clots from forming after hip replacement surgery. Dabigatran is an anticoagulant that works by blocking a certain substance (a clotting protein called thrombin) in your blood. This helps to keep blood flowing smoothly in your body. Dabigatran should not be used to prevent blood clots from forming after artificial heart valve replacement. If you have had heart valve surgery, talk to your doctor about the best medication for you. Do not stop taking any medication, including dabigatran, without talking to your doctor first.

Regulatory & Marketing

Labeler Name
Msn Laboratories Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
10-11-2011
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 14501-0071-2 identifies a specific commercial package of 50 kg in 1 drum of Dabigatran Etexilate Mesylate (UNFINISHED drug), a bulk ingredient labeled by Msn Laboratories Private Limited. This powder is formulated for use and contains dabigatran etexilate mesylate 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 Msn Laboratories Private Limited on October 11, 2011. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Dabigatran is used to prevent stroke and harmful blood clots (such as in your legs or lungs) if you have a certain type of irregular heartbeat (atrial fibrillation). Dabigatran is also used to treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) and to reduce the risk of them occurring again. This medication may also be used to prevent these blood clots from forming after hip replacement surgery. Dabigatran is an anticoagulant that works by blocking a certain substance (a clotting protein called thrombin) in your blood. This helps to keep blood flowing smoothly in your body. Dabigatran should not be used to prevent blood clots from forming after artificial heart valve replacement. If you have had heart valve surgery, talk to your doctor about the best medication for you. Do not stop taking any medication, including dabigatran, without talking to your doctor first.

How is this Msn Laboratories Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 14501007102. 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)
14501-0071-2
11-Digit CMS (5-4-2)
14501-0071-02

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