Pradaxa
NDC Package 50090-3617-0

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

Pradaxa 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). Marketed by A-s Medication Solutions, this product is identified by NDC 50090-3617 and is authorized under FDA application NDA022512.

Identification & Billing

NDC Package Code
50090-3617-0
Package Description
1 BOTTLE in 1 CARTON / 60 CAPSULE in 1 BOTTLE
Product Code
50090-3617
11-Digit Billing Format
50090361700
RxNorm Crosswalk
  • RxCUI: 1037045 - dabigatran etexilate 150 MG Oral Capsule
  • RxCUI: 1037045 - dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral Capsule
  • RxCUI: 1037049 - Pradaxa 150 MG Oral Capsule
  • RxCUI: 1037049 - dabigatran etexilate 150 MG Oral Capsule [Pradaxa]
  • RxCUI: 1037049 - Pradaxa 150 MG (as dabigatran etexilate mesylate 172.95 MG) Oral Capsule

Clinical Specifications

Proprietary Name
Pradaxa
Dosage Form
-
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
A-s Medication Solutions
FDA Application #
NDA022512
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-28-2017
Listing Expiration
12-31-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50090-3617-0 identifies a specific commercial package of 1 bottle in 1 carton / 60 capsule in 1 bottle of Pradaxa, labeled by A-s Medication Solutions. 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 A-s Medication Solutions on July 28, 2017. The current certification is valid through December 31, 2022.

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 A-s Medication Solutions product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50090361700. 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)
50090-3617-0
11-Digit CMS (5-4-2)
50090-3617-00

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