Rivaroxaban Granule For Suspension
NDC Package 70748-355-01

11-digit billing NDC: 70748035501 · Billing unit: ML
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Rivaroxaban Granule for suspensions is rivaroxaban for oral suspension is contraindicated in patients with:active pathological bleeding [see Warnings and Precautions (5.2)]severe hypersensitivity reaction to rivaroxaban for oral suspension (e.g., anaphylactic reactions) [see Adverse Reactions (6.2)]. This formulation utilizes a for suspension delivery system. Marketed by Lupin Pharmaceuticals, Inc., this product is identified by NDC 70748-355 and is authorized under FDA application ANDA218195.

Identification & Billing

NDC Package Code
70748-355-01
Package Description
1 BOTTLE in 1 CARTON / 1 FOR SUSPENSION in 1 BOTTLE
Product Code
70748-355
11-Digit Billing Format
70748035501
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rivaroxaban Granule
Non-Proprietary Name
Rivaroxaban Granule
Substance Name
Rivaroxaban
Dosage Form
For Suspension - A product, usually a solid, intended for suspension prior to administration.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
RIVAROXABAN 155 mg/1
Pharmacologic Class
Usage Information
Rivaroxaban for oral suspension is contraindicated in patients with:active pathological bleeding [see Warnings and Precautions (5.2)]severe hypersensitivity reaction to rivaroxaban for oral suspension (e.g., anaphylactic reactions) [see Adverse Reactions (6.2)]

Regulatory & Marketing

Labeler Name
Lupin Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA218195
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-29-2025
Listing Expiration
12-31-2027
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 70748-355-01 identifies a specific commercial package of 1 bottle in 1 carton / 1 for suspension in 1 bottle of Rivaroxaban Granule, a human prescription drug labeled by Lupin Pharmaceuticals, Inc.. This for suspension 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 Lupin Pharmaceuticals, Inc. on September 29, 2025. The current certification is valid through December 31, 2027.

How is this Lupin Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70748035501. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
70748-355-01
11-Digit CMS (5-4-2)
70748-0355-01

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