Hemorrhoidal
NDC Package 54162-044-02

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.

Hemorrhoidal is adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue.Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this ointmentApply to affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.For Intrarectal useRemove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert into the rectum.Thoroughly cleanse applicator after each useAlso apply ointment to external areaRegular use provides continual therapy for relief of symptomsChildren under 12 years of age, consult a doctor. Marketed by Geritrex Llc, this product is identified by NDC 54162-044 and is authorized under FDA application part346.

Identification & Billing

NDC Package Code
54162-044-02
Package Description
57 g in 1 TUBE, WITH APPLICATOR
Product Code
54162-044
11-Digit Billing Format
54162004402
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
57 GM
RxNorm Crosswalk
  • RxCUI: 1313818 - mineral oil 14 % / petrolatum 71.9 % / phenylephrine HCl 0.25 % Rectal Ointment
  • RxCUI: 1313818 - mineral oil 0.14 MG/MG / petrolatum 0.719 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment
  • RxCUI: 1313818 - mineral oil 14 % / petrolatum 71.9 % / phenylephrine hydrochloride 0.25 % Rectal Ointment

Clinical Specifications

Proprietary Name
Hemorrhoidal
Dosage Form
-
Usage Information
Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue.Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this ointmentApply to affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.For Intrarectal useRemove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert into the rectum.Thoroughly cleanse applicator after each useAlso apply ointment to external areaRegular use provides continual therapy for relief of symptomsChildren under 12 years of age, consult a doctor

Regulatory & Marketing

Labeler Name
Geritrex Llc
FDA Application #
part346
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
07-31-2015
Listing Expiration
12-31-2019
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 54162-044-02 identifies a specific commercial package of 57 g in 1 tube, with applicator of Hemorrhoidal, labeled by Geritrex Llc. This product is billed per "GM" gram and contains an estimated amount of 57 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 Geritrex Llc on July 31, 2015. The current certification is valid through December 31, 2019.

How is this Geritrex Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54162004402. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 57 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)
54162-044-02
11-Digit CMS (5-4-2)
54162-0044-02

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