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  5. NDC Package Code: 45802-050-03 Dibucaine

NDC Package 45802-050-03 Dibucaine

Ointment 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:
45802-050-03
Package Description:
1 TUBE in 1 CARTON / 28 g in 1 TUBE
Product Code:
45802-050
Proprietary Name:
Dibucaine
Non-Proprietary Name:
Dibucaine
Substance Name:
Dibucaine
Usage Information:
For hemorrhoidal:•adults and children 12 years & older: when practical, clean 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 applying.•apply externally to the affected area up to 3 or 4 times daily•children under 12 years of age: ask a doctorfor topical analgesic:•adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily•children under 2 years of age: ask a doctor
11-Digit NDC Billing Format:
45802005003
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
28 GM
NDC to RxNorm Crosswalk:
  • RxCUI: 198601 - dibucaine 1 % Topical Ointment
  • RxCUI: 198601 - dibucaine 0.01 MG/MG Topical Ointment
  • RxCUI: 198601 - dibucaine 1 GM per 100 GM Topical Ointment.
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Padagis Israel Pharmaceuticals Ltd
    Dosage Form:
    Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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):
  • DIBUCAINE 1 g/100g
    • Pharmacologic Class(es):
  • Allergens - [CS]
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Standardized Chemical Allergen - [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:
    06-20-2011
    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 45802-050-03?

    The NDC Packaged Code 45802-050-03 is assigned to a package of 1 tube in 1 carton / 28 g in 1 tube of Dibucaine, a human over the counter drug labeled by Padagis Israel Pharmaceuticals Ltd. The product's dosage form is ointment and is administered via topical form.

    Is NDC 45802-050 included in the NDC Directory?

    Yes, Dibucaine with product code 45802-050 is active and included in the NDC Directory. The product was first marketed by Padagis Israel Pharmaceuticals Ltd on June 20, 2011 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 NDC billing unit for package 45802-050-03?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 28.

    What is the 11-digit format for NDC 45802-050-03?

    The 11-digit format is 45802005003. 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
    5-3-245802-050-035-4-245802-0050-03