Proctofoam
NDC Package 21695-982-10

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.

Proctofoam is ®-HC is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region. Marketed by Rebel Distributors Corp, this product is identified by NDC 21695-982 and is authorized under FDA application ANDA086195.

Identification & Billing

NDC Package Code
21695-982-10
Package Description
1 CONTAINER in 1 CARTON / 10 g in 1 CONTAINER
Product Code
21695-982
11-Digit Billing Format
21695098210
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
10 GM
RxNorm Crosswalk
  • RxCUI: 828362 - hydrocortisone acetate 1 % / pramoxine HCl 1 % Rectal Foam
  • RxCUI: 828362 - hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Foam
  • RxCUI: 828362 - hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal Foam
  • RxCUI: 828364 - proctofoam-HC 1 % / 1 % Rectal Foam
  • RxCUI: 828364 - hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Foam [Proctofoam-HC]

Clinical Specifications

Proprietary Name
Proctofoam HC
Dosage Form
-
Usage Information
Proctofoam®-HC is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region.

Regulatory & Marketing

Labeler Name
Rebel Distributors Corp
FDA Application #
ANDA086195
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-26-1978
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 21695-982-10 identifies a specific commercial package of 1 container in 1 carton / 10 g in 1 container of Proctofoam HC, labeled by Rebel Distributors Corp. This product is billed per "GM" gram and contains an estimated amount of 10 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 Rebel Distributors Corp on July 26, 1978. The current certification is valid through December 31, 2017.

How is this Rebel Distributors Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21695098210. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 10 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)
21695-982-10
11-Digit CMS (5-4-2)
21695-0982-10

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