Ciclopirox Kit
NDC 42192-714

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 42192-714?
  4. Ciclopirox Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. Patient Education

Product Information

Ciclopirox is a UNAPPROVED DRUG OTHER-approved product labeled by Acella Pharmaceuticals, Llc. This medication is used to treat fungal infections of the fingernails and toenails. It is supplied as a kit. This product entry covers the primary NDC 42192-714 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
42192-714
Proprietary Name:
Ciclopirox
Non-Proprietary Name: [1]
Ciclopirox
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.

Labeler & Regulatory Data

Labeler Name: [5]
Acella Pharmaceuticals, Llc
Labeler Code:
42192
Product Label ID:
2c67dd09-ab1f-4ccf-97b5-421356f64f22
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
10-10-2011
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 42192-714?

The NDC code 42192-714 is assigned by the FDA to the product Ciclopirox. This pharmaceutical product is labeled by Acella Pharmaceuticals, Llc and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 42192-714-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

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Patient Education

Ciclopirox Topical


Ciclopirox topical solution is used along with regular nail trimming to treat fungal infections of the fingernails and toenails (an infection that may cause nail discoloration, splitting and pain). Ciclopirox is in a class of medications called antifungals. It works by stopping the growth of nail fungus.
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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".