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  5. NDC Package Code: 80295-100-01 Cannavera Pain Relief

NDC Package 80295-100-01 Cannavera Pain Relief

Capsaicin Oil Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
80295-100-01
Package Description:
1 BOTTLE in 1 BOX / 30 mL in 1 BOTTLE
Product Code:
80295-100
Proprietary Name:
Cannavera Pain Relief
Non-Proprietary Name:
Capsaicin
Substance Name:
Capsaicin
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
11-Digit NDC Billing Format:
80295010001
Product Type:
Human Otc Drug
Labeler Name:
Leading Edge Pharms, Inc.
Dosage Form:
Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.
Administration Route(s):
  • 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):
  • CAPSAICIN 1 mg/mL
    • Sample Package:
    No
    FDA Application Number:
    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 Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 80295-100-01?

    The NDC Packaged Code 80295-100-01 is assigned to a package of 1 bottle in 1 box / 30 ml in 1 bottle of Cannavera Pain Relief, a human over the counter drug labeled by Leading Edge Pharms, Inc.. The product's dosage form is oil and is administered via topical form.

    Is NDC 80295-100 included in the NDC Directory?

    Yes, Cannavera Pain Relief with product code 80295-100 is active and included in the NDC Directory. The product was first marketed by Leading Edge Pharms, Inc. on August 01, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 80295-100-01?

    The 11-digit format is 80295010001. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-280295-100-015-4-280295-0100-01