Lidocaine And Prilocaine
NDC Package 54868-5194-2

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Lidocaine And Prilocaine is cream, 2.5%/2.5% (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: - normal intact skin for local analgesia.  - genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5194 and is authorized under FDA application ANDA076453.

Identification & Billing

NDC Package Code
54868-5194-2
Package Description
1 TUBE in 1 CARTON / 30 g in 1 TUBE
Product Code
54868-5194
11-Digit Billing Format
54868519402
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
30 GM
RxNorm Crosswalk
  • RxCUI: 197877 - lidocaine 2.5 % / prilocaine 2.5 % Topical Cream
  • RxCUI: 197877 - lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical Cream

Clinical Specifications

Proprietary Name
Lidocaine And Prilocaine
Dosage Form
-
Usage Information
Lidocaine and prilocaine cream, 2.5%/2.5% (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: - normal intact skin for local analgesia.  - genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. Lidocaine and prilocaine cream, 2.5%/2.5% is not recommended in any clinical situation in which penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS).

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA076453
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-10-2004
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54868-5194). Click a package code to view its specific billing and regulatory data.

54868-5194-0
5 TUBE in 1 CARTON / 5 g in 1 TUBE
54868-5194-1
1 TUBE in 1 CARTON / 5 g in 1 TUBE

* 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 54868-5194-2 identifies a specific commercial package of 1 tube in 1 carton / 30 g in 1 tube of Lidocaine And Prilocaine, labeled by Physicians Total Care, Inc.. This product is billed per "GM" gram and contains an estimated amount of 30 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 Physicians Total Care, Inc. on December 10, 2004. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868519402. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 30 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 (5-4-1)
54868-5194-2
11-Digit CMS (5-4-2)
54868-5194-02

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