Libi Air Virlaza Dextromethorphan Cough Suppressant Liquid
NDC Package 84314-000-30

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

Package Information

Libi Air Virlaza Dextromethorphan Cough Suppressant (dextromethorphan) liquids is adults and children 12 years and overDissolve 1mL in 50 mL of water and take by mouth every 4 hours. This formulation utilizes a liquid delivery system. Marketed by Libi Pharm Ltd., this product is identified by NDC 84314-000 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
84314-000-30
Package Description
1 BOTTLE in 1 BOX / 30 mL in 1 BOTTLE
Product Code
84314-000
11-Digit Billing Format
84314000030

Clinical Specifications

Proprietary Name
Libi Air Virlaza Dextromethorphan Cough Suppressant
Non-Proprietary Name
Dextromethorphan
Substance Name
Dextromethorphan
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
DEXTROMETHORPHAN 10 mg/mL
Pharmacologic Class
Usage Information
Adults and children 12 years and overDissolve 1mL in 50 mL of water and take by mouth every 4 hours. Do not take more than 6 mL in 24 hours.Children 6 to under 12 years of ageDissolve 0.5 mL in 25 mL of water and take by mouth every 4 hours. Do not take more than 3 mL in 24 hours.Children under 6 years of ageConsult a doctor

Regulatory & Marketing

Labeler Name
Libi Pharm Ltd.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-07-2024
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 84314-000-30 identifies a specific commercial package of 1 bottle in 1 box / 30 ml in 1 bottle of Libi Air Virlaza Dextromethorphan Cough Suppressant, a human over the counter drug labeled by Libi Pharm Ltd.. This liquid is formulated for topical use and contains dextromethorphan 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 Libi Pharm Ltd. on January 07, 2024. The current certification is valid through December 31, 2026.

How is this Libi Pharm Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84314000030. 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)
84314-000-30
11-Digit CMS (5-4-2)
84314-0000-30

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