Sinuva Implant
NDC Package 10599-003-01

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

Package Information

Sinuva (mometasone furoate) implants is mometasone is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. This formulation utilizes a implant delivery system. Marketed by Intersect Ent, Inc., this product is identified by NDC 10599-003 and is authorized under FDA application NDA209310.

Identification & Billing

NDC Package Code
10599-003-01
Package Description
1 POUCH in 1 CARTON / 1 IMPLANT in 1 POUCH
Product Code
10599-003
11-Digit Billing Format
10599000301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sinuva
Non-Proprietary Name
Mometasone Furoate
Substance Name
Mometasone Furoate
Dosage Form
Implant - A material containing drug intended to be inserted securely of deeply in a living site for growth, slow release, or formation of an organic union.
Administration Route
Intrasinal - Administration within the nasal or periorbital sinuses.
Active Ingredient(s)
MOMETASONE FUROATE 1350 ug/1
Pharmacologic Class
Usage Information
Mometasone is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed. Mometasone belongs to a class of drugs known as corticosteroids. It works by reducing the irritation and swelling of the airways. Controlling symptoms of breathing problems can decrease time lost from work or school.

Regulatory & Marketing

Labeler Name
Intersect Ent, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA209310
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-01-2018
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J7402
Source: ASP
Mometasone sinus sinuva
HCPCS Dosage 10 MCG
Units / Pkg 135

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 10599-003-01 identifies a specific commercial package of 1 pouch in 1 carton / 1 implant in 1 pouch of Sinuva, a human prescription drug labeled by Intersect Ent, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This implant is formulated for intrasinal use and contains mometasone furoate 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 Intersect Ent, Inc. on February 01, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Mometasone is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed. Mometasone belongs to a class of drugs known as corticosteroids. It works by reducing the irritation and swelling of the airways. Controlling symptoms of breathing problems can decrease time lost from work or school.

How is this Intersect Ent, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10599000301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
10599-003-01
11-Digit CMS (5-4-2)
10599-0003-01

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