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  5. NDC Package Code: 60505-4347-6 Dabigatran Etexilate

NDC Package 60505-4347-6 Dabigatran Etexilate

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:
60505-4347-6
Package Description:
60 CAPSULE in 1 BOTTLE
Product Code:
60505-4347
Proprietary Name:
Dabigatran Etexilate
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:
60505434706
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
60 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: 1037179 - dabigatran etexilate 75 MG Oral Capsule
  • RxCUI: 1037179 - dabigatran etexilate 75 MG (as dabigatran etexilate mesylate 86.48 MG) Oral Capsule
  • RxCUI: 1723476 - dabigatran etexilate 110 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Apotex Corp.
    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 75 mg/1
    • Pharmacologic Class(es):
  • Direct Thrombin Inhibitor - [EPC] (Established Pharmacologic Class)
  • Thrombin Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA208070
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-13-2024
    Listing Expiration Date:
    12-31-2025
    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
    60505-4347-210 BLISTER PACK in 1 CARTON / 6 CAPSULE in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 60505-4347-6?

    The NDC Packaged Code 60505-4347-6 is assigned to a package of 60 capsule in 1 bottle of Dabigatran Etexilate, a human prescription drug labeled by Apotex Corp.. The product's dosage form is capsule and is administered via oral form.

    Is NDC 60505-4347 included in the NDC Directory?

    Yes, Dabigatran Etexilate with product code 60505-4347 is active and included in the NDC Directory. The product was first marketed by Apotex Corp. on February 13, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 60505-4347-6?

    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 60.

    What is the 11-digit format for NDC 60505-4347-6?

    The 11-digit format is 60505434706. 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 5-4-1 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
    5-4-160505-4347-65-4-260505-4347-06