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  5. NDC Package Code: 0597-0108-54 Pradaxa

NDC Package 0597-0108-54 Pradaxa

Dabigatran Etexilate Mesylate Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0597-0108-54
Package Description:
1 BOTTLE in 1 CARTON / 60 CAPSULE in 1 BOTTLE
Product Code:
0597-0108
Proprietary Name:
Pradaxa
Non-Proprietary Name:
Dabigatran Etexilate Mesylate
Substance Name:
Dabigatran Etexilate Mesylate
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.
11-Digit NDC Billing Format:
00597010854
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Boehringer Ingelheim Pharmaceuticals Inc.
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DABIGATRAN ETEXILATE MESYLATE 110 mg/1
    • Pharmacologic Class(es):
  • Direct Thrombin Inhibitor - [EPC] (Established Pharmacologic Class)
  • Thrombin Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA022512
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-23-2015
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0597-0108-6010 BLISTER PACK in 1 CARTON / 6 CAPSULE in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0597-0108-54?

    The NDC Packaged Code 0597-0108-54 is assigned to a package of 1 bottle in 1 carton / 60 capsule in 1 bottle of Pradaxa, a human prescription drug labeled by Boehringer Ingelheim Pharmaceuticals Inc.. The product's dosage form is capsule and is administered via oral form.

    Is NDC 0597-0108 included in the NDC Directory?

    Yes, Pradaxa with product code 0597-0108 is active and included in the NDC Directory. The product was first marketed by Boehringer Ingelheim Pharmaceuticals Inc. on November 23, 2015 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0597-0108-54?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 0597-0108-54?

    The 11-digit format is 00597010854. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20597-0108-545-4-200597-0108-54