Hydrocortisone Acetate Pramoxine Hydrochloride
NDC Package 75834-197-01

11-digit billing NDC: 75834019701 · Billing unit: GM · 28.5 GM per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Hydrocortisone Acetate Pramoxine Hydrochloride is topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. 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

Clinical Specifications

Proprietary Name
Hydrocortisone Acetate Pramoxine Hydrochloride
Dosage Form
-
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.
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
End Marketing Date
09-10-2026
Listing Expiration
09-10-2026
Exclude Flag
D
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, 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 is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Nivagen Pharmaceuticals Inc. on April 29, 2019. The current certification is valid through September 10, 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.