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  5. NDC Package Code: 50066-001-01 Nikzon Hemorrhoidal

NDC Package 50066-001-01 Nikzon Hemorrhoidal

Phenylephrine Hydrochloride And Pramoxine Hydrochloride Cream 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:
50066-001-01
Package Description:
1 TUBE in 1 BOX / 25 g in 1 TUBE
Product Code:
50066-001
Proprietary Name:
Nikzon Hemorrhoidal
Non-Proprietary Name:
Phenylephrine Hydrochloride And Pramoxine Hydrochloride
Substance Name:
Phenylephrine Hydrochloride; Pramoxine Hydrochloride
Usage Information:
Remove cap and lift foil safety seal from tube.Adults: When practical, cleanse the affected area with mild soap and warm water, and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.Apply externally to the affected area with a thin layer up to 4 times daily.Children under 12 years of age: consult a doctor.
11-Digit NDC Billing Format:
50066000101
NDC to RxNorm Crosswalk:
  • RxCUI: 1293856 - phenylephrine HCl 0.25 % / pramoxine HCl 1 % Rectal Cream
  • RxCUI: 1293856 - phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream
  • RxCUI: 1293856 - phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % Rectal Cream
  • RxCUI: 1487925 - Nikzon 0.25 % / 1 % Rectal Cream
  • RxCUI: 1487925 - phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream [Nikzon]
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Genoma Lab Usa Inc
    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.
    • Active Ingredient(s):
  • PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/g
  • PRAMOXINE HYDROCHLORIDE 10 mg/g
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • 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:
    12-01-2013
    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 50066-001-01?

    The NDC Packaged Code 50066-001-01 is assigned to a package of 1 tube in 1 box / 25 g in 1 tube of Nikzon Hemorrhoidal, a human over the counter drug labeled by Genoma Lab Usa Inc. The product's dosage form is cream and is administered via topical form.

    Is NDC 50066-001 included in the NDC Directory?

    Yes, Nikzon Hemorrhoidal with product code 50066-001 is active and included in the NDC Directory. The product was first marketed by Genoma Lab Usa Inc on December 01, 2013 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 50066-001-01?

    The 11-digit format is 50066000101. 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
    5-3-250066-001-015-4-250066-0001-01