Rivfloza Injection, Solution
NDC Package 0169-5307-08

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

Package Information

Rivfloza (nedosiran) injection is rIVFLOZA is indicated to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR ≥ 30 mL/min/1.73 m2[seeClinical Pharmacology (‎12.3)], Clinical Studies (‎14.1)]. This formulation utilizes a injection, solution delivery system. Marketed by Novo Nordisk, this product is identified by NDC 0169-5307 and is authorized under FDA application NDA215842.

Identification & Billing

NDC Package Code
0169-5307-08
Package Description
1 SYRINGE in 1 CARTON / .8 mL in 1 SYRINGE
Product Code
0169-5307
11-Digit Billing Format
00169530708
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rivfloza
Non-Proprietary Name
Nedosiran
Substance Name
Nedosiran Sodium
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
NEDOSIRAN SODIUM 128 mg/.8mL
Usage Information
RIVFLOZA is indicated to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR ≥ 30 mL/min/1.73 m2[seeClinical Pharmacology (‎12.3)], Clinical Studies (‎14.1)].

Regulatory & Marketing

Labeler Name
Novo Nordisk
Product Type
Human Prescription Drug
FDA Application #
NDA215842
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-19-2024
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 0169-5307-08 identifies a specific commercial package of 1 syringe in 1 carton / .8 ml in 1 syringe of Rivfloza, a human prescription drug labeled by Novo Nordisk. This injection, solution is formulated for subcutaneous use and contains nedosiran sodium 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 Novo Nordisk on February 19, 2024. The current certification is valid through December 31, 2026.

How is this Novo Nordisk product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00169530708. 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 (4-4-2)
0169-5307-08
11-Digit CMS (5-4-2)
00169-5307-08

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