Dermacinrx Prikaan
NDC Package 69621-873-00

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.

Dermacinrx Prikaan is lidocaine and prilocaine 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. Marketed by Shoreline Pharmaceuticals, Inc., this product is identified by NDC 69621-873 and is authorized under FDA application NDA019941.

Identification & Billing

NDC Package Code
69621-873-00
Package Description
1 KIT in 1 PACKAGE * 1 TUBE in 1 CARTON (0591-2070-30) / 30 g in 1 TUBE
Product Code
69621-873
11-Digit Billing Format
69621087300
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
Dermacinrx Prikaan
Dosage Form
-
Usage Information
Lidocaine and prilocaine 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 and prilocaine 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
Shoreline Pharmaceuticals, Inc.
FDA Application #
NDA019941
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
07-01-2016
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69621-873-00 identifies a specific commercial package of 1 kit in 1 package * 1 tube in 1 carton (0591-2070-30) / 30 g in 1 tube of Dermacinrx Prikaan, labeled by Shoreline Pharmaceuticals, Inc.. 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 Shoreline Pharmaceuticals, Inc. on July 01, 2016. The current certification is valid through December 31, 2017.

How is this Shoreline Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69621087300. 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)
69621-873-00
11-Digit CMS (5-4-2)
69621-0873-00

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