Ciclopirox Olamine
NDC Package 69315-309-30

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 inactivated by the FDA.

Ciclopirox Olamine is ciclopirox Topical Suspension, USP 0.77% is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; ; cutaneous candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur. Marketed by Leading Pharma, Llc, this product is identified by NDC 69315-309 and is authorized under FDA application NDA019824.

Identification & Billing

NDC Package Code
69315-309-30
Package Description
30 mL in 1 BOTTLE
Product Code
69315-309
11-Digit Billing Format
69315030930
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
30 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ciclopirox Olamine
Dosage Form
-
Usage Information
Ciclopirox Topical Suspension, USP 0.77% is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; ; cutaneous candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.

Regulatory & Marketing

Labeler Name
Leading Pharma, Llc
FDA Application #
NDA019824
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
12-01-2016
Listing Expiration
12-31-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69315-309). Click a package code to view its specific billing and regulatory data.

69315-309-60
60 mL in 1 BOTTLE

* 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 69315-309-30 identifies a specific commercial package of 30 ml in 1 bottle of Ciclopirox Olamine, labeled by Leading Pharma, 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 Leading Pharma, Llc on December 01, 2016. The current certification is valid through December 31, 2023.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69315030930. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-3-2)
69315-309-30
11-Digit CMS (5-4-2)
69315-0309-30

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