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  5. NDC Package Code: 75834-197-01 Hydrocortisone Acetate Pramoxine Hydrochloride

NDC Package 75834-197-01 Hydrocortisone Acetate Pramoxine Hydrochloride

Pramoxine Hydrochloride And Hydrocortisone Acetate 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:
75834-197-01
Package Description:
1 TUBE, WITH APPLICATOR in 1 CARTON / 28.5 g in 1 TUBE, WITH APPLICATOR
Product Code:
75834-197
Proprietary Name:
Hydrocortisone Acetate Pramoxine Hydrochloride
Non-Proprietary Name:
Pramoxine Hydrochloride And Hydrocortisone Acetate
Substance Name:
Hydrocortisone Acetate; Pramoxine Hydrochloride
Usage Information:
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
11-Digit NDC Billing Format:
75834019701
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
28.5 GM
NDC to RxNorm Crosswalk:
  • RxCUI: 1294025 - hydrocortisone acetate 2.5 % / pramoxine HCl 1 % Rectal Cream
  • RxCUI: 1294025 - hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream
  • RxCUI: 1294025 - hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Rectal Cream
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Nivagen Pharmaceuticals 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):
  • HYDROCORTISONE ACETATE 25 mg/g
  • PRAMOXINE HYDROCHLORIDE 10 mg/g
    • Pharmacologic Class(es):
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    Marketing Category:
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date:
    04-29-2019
    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 75834-197-01?

    The NDC Packaged Code 75834-197-01 is assigned to a package of 1 tube, with applicator in 1 carton / 28.5 g in 1 tube, with applicator of Hydrocortisone Acetate Pramoxine Hydrochloride, a human prescription drug labeled by Nivagen Pharmaceuticals Inc.. The product's dosage form is cream and is administered via topical form.This product is billed per "GM" gram and contains an estimated amount of 28.5 billable units per package.

    Is NDC 75834-197 included in the NDC Directory?

    Yes, Hydrocortisone Acetate Pramoxine Hydrochloride with product code 75834-197 is active and included in the NDC Directory. The product was first marketed by Nivagen Pharmaceuticals Inc. on April 29, 2019 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 75834-197-01?

    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 28.5.

    What is the 11-digit format for NDC 75834-197-01?

    The 11-digit format is 75834019701. 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
    5-3-275834-197-015-4-275834-0197-01