Quality Choice Nasal
NDC Package 63868-080-01

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.

Quality Choice Nasal is •adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Marketed by Quality Choice (chain Drug Marketing Association), this product is identified by NDC 63868-080 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
63868-080-01
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 30 mL in 1 BOTTLE, SPRAY
Product Code
63868-080
11-Digit Billing Format
63868008001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Quality Choice Nasal Maximum Strength
Dosage Form
-
Usage Information
•adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.•children under 6 years of age: ask a doctorShake well before use. Before using the first time, remove the protective cap from the tip by pressing and twisting off the cap. Rotate the lock tab to align arrow marks to unlock the pump. Prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Lock the pump by ensuring that arrow marks are not aligned and replace the proactive cap on tip.

Regulatory & Marketing

Labeler Name
Quality Choice (chain Drug Marketing Association)
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
04-16-2019
Listing Expiration
12-31-2023
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 63868-080-01 identifies a specific commercial package of 1 bottle, spray in 1 carton / 30 ml in 1 bottle, spray of Quality Choice Nasal Maximum Strength, labeled by Quality Choice (chain Drug Marketing Association). 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 Quality Choice (chain Drug Marketing Association) on April 16, 2019. The current certification is valid through December 31, 2023.

How is this Quality Choice (chain Drug Marketing Association) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63868008001. 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)
63868-080-01
11-Digit CMS (5-4-2)
63868-0080-01

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