NDC Package 0597-0107-60 Pradaxa

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory .

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:
0597-0107-60
Package Description:
10 BLISTER PACK in 1 CARTON / 6 CAPSULE in 1 BLISTER PACK
Product Code:
Proprietary Name:
Pradaxa
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:
00597010760
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
10 EA
Labeler Name:
Boehringer Ingelheim Pharmaceuticals Inc.
Sample Package:
No
FDA Application Number:
NDA022512
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
11-08-2010
End Marketing Date:
09-20-2013
Listing Expiration Date:
09-20-2013
Exclude Flag:
D
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.

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Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
0597-0107-541 BOTTLE in 1 CARTON / 60 CAPSULE in 1 BOTTLE

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Frequently Asked Questions

What is NDC 0597-0107-60?

The NDC Packaged Code 0597-0107-60 is assigned to a package of 10 blister pack in 1 carton / 6 capsule in 1 blister pack of Pradaxa, labeled by Boehringer Ingelheim Pharmaceuticals Inc.. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package.

Is NDC 0597-0107 included in the NDC Directory?

The product was first marketed by Boehringer Ingelheim Pharmaceuticals Inc. on November 08, 2010 and its listing in the NDC Directory is set to expire on September 20, 2013 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0597-0107-60?

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 10.

What is the 11-digit format for NDC 0597-0107-60?

The 11-digit format is 00597010760. 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
4-4-20597-0107-605-4-200597-0107-60