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  5. NDC Package Code: 0597-0445-87 Pradaxa

NDC Package 0597-0445-87 Pradaxa

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

Table of Contents

    1. Package Information
    2. 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:
0597-0445-87
Package Description:
1 BAG in 1 CARTON / 60 PELLET in 1 BAG
Product Code:
0597-0445
Proprietary Name:
Pradaxa
Non-Proprietary Name:
Dabigatran Etexilate
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:
00597044587
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: 2590616 - dabigatran etexilate 110 MG Oral Pellet
  • RxCUI: 2590616 - dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral Pellet
  • RxCUI: 2590619 - Pradaxa 110 MG Oral Pellet
  • RxCUI: 2590619 - dabigatran etexilate 110 MG Oral Pellet [Pradaxa]
  • RxCUI: 2590620 - dabigatran etexilate 150 MG Oral Pellet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Boehringer Ingelheim Pharmaceuticals, Inc.
    Dosage Form:
    Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.
    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:
    NDA214358
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-16-2022
    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.

    Frequently Asked Questions

    What is NDC 0597-0445-87?

    The NDC Packaged Code 0597-0445-87 is assigned to a package of 1 bag in 1 carton / 60 pellet in 1 bag of Pradaxa, a human prescription drug labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. The product's dosage form is pellet and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 0597-0445 included in the NDC Directory?

    Yes, Pradaxa with product code 0597-0445 is active and included in the NDC Directory. The product was first marketed by Boehringer Ingelheim Pharmaceuticals, Inc. on March 16, 2022 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 0597-0445-87?

    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 0597-0445-87?

    The 11-digit format is 00597044587. 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
    4-4-20597-0445-875-4-200597-0445-87