NDC Package 43749-470-01 Avedana Hemorrhoidal Maximum Strength

Hemorrhoidal Cream Topical - 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:
43749-470-01
Package Description:
1 TUBE in 1 CARTON / 25.5 g in 1 TUBE (43749-470-03)
Product Code:
Proprietary Name:
Avedana Hemorrhoidal Maximum Strength
Non-Proprietary Name:
Hemorrhoidal
Substance Name:
Glycerin; Petrolatum; Phenylephrine Hydrochloride; Pramoxine Hydrochloride
Usage Information:
-adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.  Gently dry by patting or blotting with a tissue or a soft cloth before applying cream.  When first opening the tube, puncture foil seal with top end of cap.  Apply externally or in the lower portion of the anal canal only.  Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement. -For application in the lower anal canal: remove cover from dispensing cap.  Attach dispensing cap to tube.  Lubrcate dispensing cap well, then gently insert dispensing cap partway into the anus.-thoroughly cleanse dispensing cap after each use and replace cover.-children under 12 years of age: ask a doctor. Apply externally or in the lower portion of the anal canal only. Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.-For application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubrcate dispensing cap well, then gently insert dispensing cap partway into the anus.
11-Digit NDC Billing Format:
43749047001
Product Type:
Human Otc Drug
Labeler Name:
Unipack Llc
Dosage Form:
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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
    FDA Application Number:
    part346
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    11-04-2020
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    43749-470-021 TUBE in 1 CARTON / 51 g in 1 TUBE (43749-470-04)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 43749-470-01?

    The NDC Packaged Code 43749-470-01 is assigned to a package of 1 tube in 1 carton / 25.5 g in 1 tube (43749-470-03) of Avedana Hemorrhoidal Maximum Strength, a human over the counter drug labeled by Unipack Llc. The product's dosage form is cream and is administered via topical form.

    Is NDC 43749-470 included in the NDC Directory?

    Yes, Avedana Hemorrhoidal Maximum Strength with product code 43749-470 is active and included in the NDC Directory. The product was first marketed by Unipack Llc on November 04, 2020 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 43749-470-01?

    The 11-digit format is 43749047001. 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
    5-3-243749-470-015-4-243749-0470-01