Hydrocortisone Acetate Pramoxine Hydrochloride Cream
NDC Package 75834-197-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Hydrocortisone Acetate Pramoxine Hydrochloride (pramoxine hydrochloride and hydrocortisone acetate) cream is topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. This formulation utilizes a cream delivery system. Marketed by Nivagen Pharmaceuticals Inc., this product is identified by NDC 75834-197.

Identification & Billing

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
11-Digit Billing Format
75834019701
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
28.5 GM
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

Clinical Specifications

Proprietary Name
Hydrocortisone Acetate Pramoxine Hydrochloride
Non-Proprietary Name
Pramoxine Hydrochloride And Hydrocortisone Acetate
Substance Name
Hydrocortisone Acetate; Pramoxine Hydrochloride
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
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)
Pharmacologic Class
Usage Information
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Regulatory & Marketing

Labeler Name
Nivagen Pharmaceuticals Inc.
Product Type
Human Prescription Drug
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
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 75834-197-01 identifies a specific commercial 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.. This product is billed per "GM" gram and contains an estimated amount of 28.5 billable units per package. This cream is formulated for topical use and contains hydrocortisone acetate; pramoxine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Nivagen Pharmaceuticals Inc. on April 29, 2019. The current certification is valid through December 31, 2026.

How is this Nivagen Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75834019701. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 28.5 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
75834-197-01
11-Digit CMS (5-4-2)
75834-0197-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.