Efinaconazole
NDC Package 0574-0155-04

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 discontinued by the firm.

Efinaconazole is a . Marketed by Padagis Us Llc, this product is identified by NDC 0574-0155 and is authorized under FDA application ANDA211851.

Identification & Billing

NDC Package Code
0574-0155-04
Package Description
1 BOTTLE, WITH APPLICATOR in 1 CARTON / 4 mL in 1 BOTTLE, WITH APPLICATOR
Product Code
0574-0155
11-Digit Billing Format
00574015504

Clinical Specifications

Proprietary Name
Efinaconazole
Dosage Form
-

Regulatory & Marketing

Labeler Name
Padagis Us Llc
FDA Application #
ANDA211851
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-16-2020
End Marketing Date
12-16-2020
Listing Expiration
12-16-2020
Exclude Flag
D
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 (0574-0155). Click a package code to view its specific billing and regulatory data.

0574-0155-08
1 BOTTLE, WITH APPLICATOR in 1 CARTON / 8 mL in 1 BOTTLE, WITH APPLICATOR

* 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 0574-0155-04 identifies a specific commercial package of 1 bottle, with applicator in 1 carton / 4 ml in 1 bottle, with applicator of Efinaconazole, labeled by Padagis Us Llc. 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 Padagis Us Llc on December 16, 2020. The current certification is valid through December 16, 2020.

How is this Padagis Us Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00574015504. 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)
0574-0155-04
11-Digit CMS (5-4-2)
00574-0155-04

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