Rivaroxaban Granule For Suspension
NDC Package 70748-355-01
Package Information
Rivaroxaban Granule for suspensions 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 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
- RxCUI: 2588062 - rivaroxaban 1 MG/mL Oral Suspension
- RxCUI: 2588062 - rivaroxaban 1 MG/ML Oral Suspension
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 70748 - Lupin Pharmaceuticals, Inc.
- 70748-355 - Rivaroxaban Granule
- 70748-355-01 - 1 BOTTLE in 1 CARTON / 1 FOR SUSPENSION in 1 BOTTLE
- 70748-355 - Rivaroxaban Granule
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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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.
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 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.