Lidocaine And Prilocaine Cream
NDC Package 68071-1625-3

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

Package Information

Lidocaine And Prilocaine cream is lidocaine 2.5% and prilocaine 2.5% cream (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 Nucare Pharamceuticals,inc., this product is identified by NDC 68071-1625 and is authorized under FDA application ANDA076290.

Identification & Billing

NDC Package Code
68071-1625-3
Package Description
30 g in 1 BOX
Product Code
68071-1625
11-Digit Billing Format
68071162503
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
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 2.5% and prilocaine 2.5% cream (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 2.5% and prilocaine 2.5% cream 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
Nucare Pharamceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA076290
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-25-2003
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68071-1625-3 identifies a specific commercial package of 30 g in 1 box of Lidocaine And Prilocaine, a human prescription drug labeled by Nucare Pharamceuticals,inc.. This product is billed per "GM" gram and contains an estimated amount of 30 billable units per package. 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 Nucare Pharamceuticals,inc. on September 25, 2003. The current certification is valid through December 31, 2026.

How is this Nucare Pharamceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071162503. 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)
68071-1625-3
11-Digit CMS (5-4-2)
68071-1625-03

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