NDC Compounded Drug 72934-4614-9 Ciclopirox Olamine; Terbinafine Hydrochloride; Fluconazole

Solution Topical

Table of Contents

    1. Compounded Product Information
    2. NDC Crossover Products Matching Filoma
    3. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 72934-4614
NDC Package Code 72934-4614-9
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.		 72934461409
Package Description 15 mL in 1 BOTTLE, GLASS
Product Type 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.		 Human Compounded Drug
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		 Filoma
Non-Proprietary Name 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.		 071040 Ciclopirox 8% / Fluconazole 1% / Terbinafine Hcl 1%
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		 Ciclopirox Olamine; Terbinafine Hydrochloride; Fluconazole
Dosage Form Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Route Name Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Marketing Category OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code 72934
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Sknv
Substance Name Ciclopirox Olamine; Terbinafine Hydrochloride; Fluconazole
Active Ingredients Information 8 g/100 mL; 1 g/100 mL; 1 g/100 mL
Reporting Period 2025-1

NDC Crossover Products Matching Ciclopirox Olamine; Terbinafine Hydrochloride; Fluconazole

NDC crossover of Filoma with NDC 72934-4614 a human compounded drug with other similar products matching the same substance name (Ciclopirox Olamine; Terbinafine Hydrochloride; Fluconazole) and the same administration route (topical) or dosage form (solution).

Frequently Asked Questions

What is the NDC number assigned to Hixdefrima Solution?

Hixdefrima Solution was assigned by its manufacturer with NDC product code 72934-4614. This product is a drug classified as a human compounded drug. Compounded drugs are medications created by combining or altering existing drugs to meet the specific needs of certain patients. The NDC directory only includes information about compounded drugs from facilities that choose to assign NDC numbers to their products.

Which are the NDC package codes for Hixdefrima Solution?

The NDC package code 72934-4614-9 was assigned to a 15 mL in 1 BOTTLE, GLASS of ciclopirox olamine; terbinafine hydrochloride; fluconazole administered topical via solution.

Who manufactures this product?

Hixdefrima Solution is manufactured by an outsourced facility and labeled by Sknv. All compounded drugs included in the NDC directory are classified as "Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)". Outsourcing facilities are a type of drug compounding facility regulated under Section 503B of the FD&C Act could be eligible for exemptions from drug registration if they meet all the conditions specified under Section 503B.

Which are the NDC crossover matchings for this product?

We found 3 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by SKNV with NDC product codes 72934-4360-9, 72934-4360-9 and 72934-4360-9.