Proctofoam Aerosol, Foam
NDC Package 0037-6822-10

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

Package Information

Proctofoam (pramoxine hydrochloride hydrocortisone acetate) aerosols is iNDICATIONS AND USAGE: Proctofoam®-HC is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region. This formulation utilizes a aerosol, foam delivery system. Marketed by Viatris Specialty Llc, this product is identified by NDC 0037-6822 and is authorized under FDA application ANDA086195.

Identification & Billing

NDC Package Code
0037-6822-10
Package Description
1 CANISTER in 1 CARTON / 10 g in 1 CANISTER
Product Code
0037-6822
11-Digit Billing Format
00037682210
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
Non-Proprietary Name
Pramoxine Hydrochloride Hydrocortisone Acetate
Substance Name
Hydrocortisone Acetate; Pramoxine Hydrochloride
Dosage Form
Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.
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
INDICATIONS AND USAGE: 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
Viatris Specialty Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA086195
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-15-2014
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 0037-6822-10 identifies a specific commercial package of 1 canister in 1 carton / 10 g in 1 canister of Proctofoam HC, a human prescription drug labeled by Viatris Specialty Llc. This aerosol, foam 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 Viatris Specialty Llc on August 15, 2014. The current certification is valid through December 31, 2026.

How is this Viatris Specialty Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00037682210. 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 (4-4-2)
0037-6822-10
11-Digit CMS (5-4-2)
00037-6822-10

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