Proctocort Suppository
NDC Package 65649-511-24

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

Package Information

Proctocort (hydrocortisone acetate) suppositories is a medication used to treat a variety of skin conditions (e.g., insect bites, poison oak/ivy, eczema, dermatitis, allergies, rash, itching of the outer female genitals, anal itching). This formulation utilizes a suppository delivery system. Marketed by Salix Pharmaceuticals, Inc, this product is identified by NDC 65649-511.

Identification & Billing

NDC Package Code
65649-511-24
Package Description
24 SUPPOSITORY in 1 BOX
Product Code
65649-511
11-Digit Billing Format
65649051124
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Proctocort
Non-Proprietary Name
Hydrocortisone Acetate
Substance Name
Hydrocortisone Acetate
Dosage Form
Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.
Administration Route
Rectal - Administration to the rectum.
Active Ingredient(s)
HYDROCORTISONE ACETATE 30 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat a variety of skin conditions (e.g., insect bites, poison oak/ivy, eczema, dermatitis, allergies, rash, itching of the outer female genitals, anal itching). Hydrocortisone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a mild corticosteroid.

Regulatory & Marketing

Labeler Name
Salix 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
06-01-2004
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65649-511). Click a package code to view its specific billing and regulatory data.

65649-511-12
12 SUPPOSITORY in 1 BOX

* 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 65649-511-24 identifies a specific commercial package of 24 suppository in 1 box of Proctocort, a human prescription drug labeled by Salix Pharmaceuticals, Inc. This suppository is formulated for rectal use and contains hydrocortisone acetate 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 Salix Pharmaceuticals, Inc on June 01, 2004. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a variety of skin conditions (e.g., insect bites, poison oak/ivy, eczema, dermatitis, allergies, rash, itching of the outer female genitals, anal itching). Hydrocortisone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a mild corticosteroid.

How is this Salix Pharmaceuticals, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65649051124. 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)
65649-511-24
11-Digit CMS (5-4-2)
65649-0511-24

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