NDC Package 83243-001-01 Azzurx

Melissa Officinalis Leaf, Thuja Occidentalis Leaf, Geranium Maculatum, Calendula - View Billable Units, 11-Digit Format, RxNorm

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:
83243-001-01
Package Description:
3 APPLICATOR in 1 PACKAGE / .5 mL in 1 APPLICATOR
Product Code:
Proprietary Name:
Azzurx
Non-Proprietary Name:
Melissa Officinalis Leaf, Thuja Occidentalis Leaf, Geranium Maculatum, Calendula Officinalls
Substance Name:
Calendula Officinalis Flower; Geranium Maculatum Root; Melissa Officinalis Leaf; Thuja Occidentalis Leaf
Usage Information:
Application instructionsRemove and reverse cardboard sleeve on applicator to expose swab.Crush applicator to activate by squeezing on the “X” (in AZZURX) between thumb and forefinger until you hear a snap.Rotate applicator with swab pointing downward and squeeze gently until the swab is saturated.Discard after use.At the first sign of cold sore/fever blister (tingle): Clean the area of the tingle before applying.Apply directly to face or lips at the site of the tingle.Repeat every 12 hours until all applicators are used.After cold sore/fever blister erupts (skin broken):Clean the area of the outbreak before applying.Apply directly to the affected area of the face or lips.Repeat every 24 hours as neededChildren under 12: Ask a doctor
11-Digit NDC Billing Format:
83243000101
Product Type:
Human Otc Drug
Labeler Name:
Outbreaks, Inc.
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(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.
  • Sample Package:
    No
    Marketing Category:
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date:
    02-13-2023
    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 83243-001-01?

    The NDC Packaged Code 83243-001-01 is assigned to a package of 3 applicator in 1 package / .5 ml in 1 applicator of Azzurx, a human over the counter drug labeled by Outbreaks, Inc.. The product's dosage form is liquid and is administered via topical form.

    Is NDC 83243-001 included in the NDC Directory?

    Yes, Azzurx with product code 83243-001 is active and included in the NDC Directory. The product was first marketed by Outbreaks, Inc. on February 13, 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 83243-001-01?

    The 11-digit format is 83243000101. 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
    5-3-283243-001-015-4-283243-0001-01