Ciclopirox Shampoo
NDC Package 0591-2159-90

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

Package Information

Ciclopirox shampoos is a medication used to treat fungal infections of the fingernails and toenails. This formulation utilizes a shampoo delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-2159 and is authorized under FDA application ANDA090490.

Identification & Billing

NDC Package Code
0591-2159-90
Package Description
120 mL in 1 BOTTLE, PLASTIC
Product Code
0591-2159
11-Digit Billing Format
00591215990
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
120 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ciclopirox
Non-Proprietary Name
Ciclopirox
Substance Name
Ciclopirox
Dosage Form
Shampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.
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)
CICLOPIROX 10 mg/.96mL
Pharmacologic Class
Usage Information
This medication is used to treat fungal infections of the fingernails and toenails. It is used as part of a treatment program that includes the removal of unattached, infected nails by a health care professional as frequently as once a month. Ciclopirox works by stopping the growth of fungus.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA090490
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-12-2012
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 0591-2159-90 identifies a specific commercial package of 120 ml in 1 bottle, plastic of Ciclopirox, a human prescription drug labeled by Actavis Pharma, Inc.. This shampoo is formulated for topical use and contains ciclopirox 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 Actavis Pharma, Inc. on December 12, 2012. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat fungal infections of the fingernails and toenails. It is used as part of a treatment program that includes the removal of unattached, infected nails by a health care professional as frequently as once a month. Ciclopirox works by stopping the growth of fungus.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591215990. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 120 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 (4-4-2)
0591-2159-90
11-Digit CMS (5-4-2)
00591-2159-90

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