Lidocaine And Prilocaine Cream
NDC Package 0168-0357-56

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

Lidocaine And Prilocaine cream is 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. This formulation utilizes a cream delivery system. Marketed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc, this product is identified by NDC 0168-0357 and is authorized under FDA application ANDA076453.

Identification & Billing

NDC Package Code
0168-0357-56
Package Description
1 TUBE in 1 CARTON / 5 g in 1 TUBE (0168-0357-05)
Product Code
0168-0357
11-Digit Billing Format
00168035756
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
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
Non-Proprietary Name
Lidocaine And Prilocaine
Substance Name
Lidocaine; Prilocaine
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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
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 when 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
E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA076453
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-18-2003
Listing Expiration
12-31-2027
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 (0168-0357). Click a package code to view its specific billing and regulatory data.

0168-0357-30
1 TUBE in 1 CARTON / 30 g in 1 TUBE
0168-0357-55
1 TUBE in 1 CARTON / 5 g in 1 TUBE (0168-0357-05)

* 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 0168-0357-56 identifies a specific commercial package of 1 tube in 1 carton / 5 g in 1 tube (0168-0357-05) of Lidocaine And Prilocaine, a human prescription drug labeled by E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc. This cream is formulated for topical use and contains lidocaine; prilocaine 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 E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc on August 18, 2003. The current certification is valid through December 31, 2027.

How is this E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00168035756. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
0168-0357-56
11-Digit CMS (5-4-2)
00168-0357-56

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