Sinu Inhaler
NDC Package 13709-281-07

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Sinu Inhaler is the product delivers in each 800 ml of air 0.04 to 0.150 mg of levmetamfetaminedo not use more often than every 2 hoursadults and children 12 years of age and over2 inhalations in each nostrilchildren 6 to under 12 years of age(with adult supervision)1 inhalation in each nostrilchildren under 6 years of ageask a doctorchildren under 2 years of agedo not use. Marketed by Neilmed Pharmaceuticals, Inc., this product is identified by NDC 13709-281 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
13709-281-07
Package Description
1 INHALER in 1 BLISTER PACK / 198 INHALANT in 1 INHALER
Product Code
13709-281
11-Digit Billing Format
13709028107

Clinical Specifications

Proprietary Name
Sinu Inhaler
Dosage Form
-
Usage Information
The product delivers in each 800 ml of air 0.04 to 0.150 mg of levmetamfetaminedo not use more often than every 2 hoursadults and children 12 years of age and over2 inhalations in each nostrilchildren 6 to under 12 years of age(with adult supervision)1 inhalation in each nostrilchildren under 6 years of ageask a doctorchildren under 2 years of agedo not use

Regulatory & Marketing

Labeler Name
Neilmed Pharmaceuticals, Inc.
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
06-15-2014
Listing Expiration
12-31-2022
Exclude Flag
I
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 13709-281-07 identifies a specific commercial package of 1 inhaler in 1 blister pack / 198 inhalant in 1 inhaler of Sinu Inhaler, labeled by Neilmed Pharmaceuticals, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Neilmed Pharmaceuticals, Inc. on June 15, 2014. The current certification is valid through December 31, 2022.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13709028107. 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)
13709-281-07
11-Digit CMS (5-4-2)
13709-0281-07

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