Xarelto Tablet, Film Coated
NDC Package 71610-690-42

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Xarelto (rivaroxaban) tablets is rivaroxaban is used to prevent blood clots from forming due to a certain irregular heartbeat (atrial fibrillation) or after hip or knee replacement surgery. This formulation utilizes a tablet, film coated delivery system. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 71610-690 and is authorized under FDA application NDA022406.

Identification & Billing

NDC Package Code
71610-690-42
Package Description
1800 TABLET, FILM COATED in 1 BOTTLE
Product Code
71610-690
11-Digit Billing Format
71610069042
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1800 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xarelto
Non-Proprietary Name
Rivaroxaban
Substance Name
Rivaroxaban
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
RIVAROXABAN 10 mg/1
Pharmacologic Class
Usage Information
Rivaroxaban is used to prevent blood clots from forming due to a certain irregular heartbeat (atrial fibrillation) or after hip or knee replacement surgery. It is also used to prevent blood clots from forming in high-risk patients with limited mobility during their hospital stay and after discharge. In addition, rivaroxaban is used to treat blood clots (such as in deep vein thrombosis-DVT or pulmonary embolus-PE) and to prevent the blood clots from forming again. Rivaroxaban is an anticoagulant that works by blocking certain clotting proteins in your blood.

Regulatory & Marketing

Labeler Name
Aphena Pharma Solutions - Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA022406
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-01-2011
Listing Expiration
12-31-2026
Exclude Flag
N
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 71610-690-42 identifies a specific commercial package of 1800 tablet, film coated in 1 bottle of Xarelto, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1800 billable units per package. This tablet, film coated is formulated for oral use and contains rivaroxaban as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Aphena Pharma Solutions - Tennessee, Llc on July 01, 2011. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Rivaroxaban is used to prevent blood clots from forming due to a certain irregular heartbeat (atrial fibrillation) or after hip or knee replacement surgery. It is also used to prevent blood clots from forming in high-risk patients with limited mobility during their hospital stay and after discharge. In addition, rivaroxaban is used to treat blood clots (such as in deep vein thrombosis-DVT or pulmonary embolus-PE) and to prevent the blood clots from forming again. Rivaroxaban is an anticoagulant that works by blocking certain clotting proteins in your blood.

How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71610069042. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1800 total billable units per package. 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 (5-3-2)
71610-690-42
11-Digit CMS (5-4-2)
71610-0690-42

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