Rivaroxaban Granule, For Suspension
NDC Package 63285-908-12

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Rivaroxaban granules 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 granule, for suspension delivery system. Marketed by Patheon Inc., this product is identified by NDC 63285-908.

Identification & Billing

NDC Package Code
63285-908-12
Package Description
12 BOTTLE in 1 BOX / 155 GRANULE, FOR SUSPENSION in 1 BOTTLE
Product Code
63285-908
11-Digit Billing Format
63285090812

Clinical Specifications

Proprietary Name
Rivaroxaban
Non-Proprietary Name
Rivaroxaban
Substance Name
Rivaroxaban
Dosage Form
Granule, For Suspension - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing to form a suspension; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.
Active Ingredient(s)
RIVAROXABAN 155 mg/1
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
Patheon Inc.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
12-01-2021
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 63285-908-12 identifies a specific commercial package of 12 bottle in 1 box / 155 granule, for suspension in 1 bottle of Rivaroxaban (UNFINISHED drug), drug for further processing labeled by Patheon Inc.. This granule, for suspension is formulated for 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 Patheon Inc. on December 01, 2021. 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 Patheon Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63285090812. 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)
63285-908-12
11-Digit CMS (5-4-2)
63285-0908-12

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