Cannavera Pain Relief
NDC Package 80295-100-01

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.

Cannavera Pain Relief is adults and children 18 years of age or older • Apply a thin film of oil to affected area and gently rub in until fully absorbed • Wash hands with soap and water after use • Apply to affected area not more than 3 to 4 times daily. Marketed by Leading Edge Pharms, Inc., this product is identified by NDC 80295-100 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
80295-100-01
Package Description
1 BOTTLE in 1 BOX / 30 mL in 1 BOTTLE
Product Code
80295-100
11-Digit Billing Format
80295010001

Clinical Specifications

Proprietary Name
Cannavera Pain Relief
Dosage Form
-
Usage Information
Adults and children 18 years of age or older • Apply a thin film of oil to affected area and gently rub in until fully absorbed • Wash hands with soap and water after use • Apply to affected area not more than 3 to 4 times daily. Children under 18 yearsask a doctor

Regulatory & Marketing

Labeler Name
Leading Edge Pharms, Inc.
FDA Application #
part348
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
08-01-2023
Listing Expiration
12-31-2024
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 80295-100-01 identifies a specific commercial package of 1 bottle in 1 box / 30 ml in 1 bottle of Cannavera Pain Relief, labeled by Leading Edge Pharms, 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 Leading Edge Pharms, Inc. on August 01, 2023. The current certification is valid through December 31, 2024.

How is this Leading Edge Pharms, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80295010001. 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)
80295-100-01
11-Digit CMS (5-4-2)
80295-0100-01

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