Pramoxine Hydrochloride
NDC Package 54868-5865-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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 inactivated by the FDA.

Pramoxine Hydrochloride is place cap on container. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5865 and is authorized under FDA application part346.

Identification & Billing

NDC Package Code
54868-5865-0
Package Description
1 CONTAINER in 1 CARTON / 15 g in 1 CONTAINER
Product Code
54868-5865
11-Digit Billing Format
54868586500
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
15 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pramoxine Hydrochloride
Dosage Form
-
Usage Information
Place cap on container. Shake well before use.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 proctofoam®.Dispense proctofoam® onto a clean tissue and apply externally to the affected area up to 5 times daily.Children under 12 years of age: consult a physician.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
part346
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
02-22-2008
Listing Expiration
12-31-2017
Exclude Flag
I
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 54868-5865-0 identifies a specific commercial package of 1 container in 1 carton / 15 g in 1 container of Pramoxine Hydrochloride, labeled by Physicians Total Care, Inc.. This product is billed per "GM" gram and contains an estimated amount of 15 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 Physicians Total Care, Inc. on February 22, 2008. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868586500. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 15 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 (5-4-1)
54868-5865-0
11-Digit CMS (5-4-2)
54868-5865-00

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