Vapor Inhaler Inhalant
NDC Package 63868-267-01

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

Package Information

Vapor Inhaler (levmetamfetamine nasal decongestant) inhalants 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. This formulation utilizes a inhalant delivery system. Marketed by C.d.m.a., Inc., this product is identified by NDC 63868-267 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
63868-267-01
Package Description
1 INHALER in 1 BLISTER PACK / 198 INHALANT in 1 INHALER
Product Code
63868-267
11-Digit Billing Format
63868026701
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Vapor Inhaler
Non-Proprietary Name
Levmetamfetamine Nasal Decongestant
Substance Name
Levmetamfetamine
Dosage Form
Inhalant - A special class of inhalations consisting of a drug or combination of drugs, that by virtue of their high vapor pressure can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an inhaler.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
LEVMETAMFETAMINE 50 mg/1
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
C.d.m.a., Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-2014
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 63868-267-01 identifies a specific commercial package of 1 inhaler in 1 blister pack / 198 inhalant in 1 inhaler of Vapor Inhaler, a human over the counter drug labeled by C.d.m.a., Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This inhalant is formulated for nasal use and contains levmetamfetamine 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 C.d.m.a., Inc. on January 01, 2014. The current certification is valid through December 31, 2026.

How is this C.d.m.a., Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63868026701. 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)
63868-267-01
11-Digit CMS (5-4-2)
63868-0267-01

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