Ertaczo Cream
NDC Package 73159-004-60

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

Package Information

Ertaczo (sertaconazole nitrate) cream is a medication used to treat athlete's foot. This formulation utilizes a cream delivery system. Marketed by Lacer Pharma, Llc, this product is identified by NDC 73159-004 and is authorized under FDA application NDA021385.

Identification & Billing

NDC Package Code
73159-004-60
Package Description
1 TUBE in 1 CARTON / 60 g in 1 TUBE
Product Code
73159-004
11-Digit Billing Format
73159000460
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
60 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ertaczo
Non-Proprietary Name
Sertaconazole Nitrate
Substance Name
Sertaconazole Nitrate
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)
SERTACONAZOLE NITRATE 20 mg/g
Pharmacologic Class
Usage Information
This medication is used to treat athlete's foot. It is an azole antifungal that works by preventing the growth of fungus.

Regulatory & Marketing

Labeler Name
Lacer Pharma, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021385
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-26-2024
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 73159-004-60 identifies a specific commercial package of 1 tube in 1 carton / 60 g in 1 tube of Ertaczo, a human prescription drug labeled by Lacer Pharma, Llc. This product is billed per "GM" gram and contains an estimated amount of 60 billable units per package. This cream is formulated for topical use and contains sertaconazole nitrate 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 Lacer Pharma, Llc on November 26, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat athlete's foot. It is an azole antifungal that works by preventing the growth of fungus.

How is this Lacer Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73159000460. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 60 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)
73159-004-60
11-Digit CMS (5-4-2)
73159-0004-60

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