Dibucaine
NDC Package 54162-011-01

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.

Dibucaine is not for prolonged useAdults should not use more than 1oz in 24 hours or 1/4 oz for childApply to affected area 3 or 4 times dailyCover with light dressing, if necessary. Marketed by Geritrex Llc, this product is identified by NDC 54162-011 and is authorized under FDA application part346.

Identification & Billing

NDC Package Code
54162-011-01
Package Description
28 g in 1 TUBE
Product Code
54162-011
11-Digit Billing Format
54162001101
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
28 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dibucaine
Dosage Form
-
Usage Information
Not for prolonged useAdults should not use more than 1oz in 24 hours or 1/4 oz for childApply to affected area 3 or 4 times dailyCover with light dressing, if necessary

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 54162-011-01 identifies a specific commercial package of 28 g in 1 tube of Dibucaine, labeled by Geritrex Llc. This product is billed per "GM" gram and contains an estimated amount of 28 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: 54162001101. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 28 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)
54162-011-01
11-Digit CMS (5-4-2)
54162-0011-01

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