MedPath

Ciclopirox

Ciclopirox Treatment Kit

Approved
Approval ID

2c67dd09-ab1f-4ccf-97b5-421356f64f22

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 18, 2024

Manufacturers
FDA

Acella Pharmaceuticals, LLC

DUNS: 825380939

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ciclopirox

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42192-714
Product Classification
G
Generic Name
Ciclopirox
Product Specifications
Effective DateJanuary 18, 2024
FDA Product Classification

Drug Labeling Information

CLINICAL PHARMACOLOGY SECTION

LOINC: 34090-1Updated: 4/1/2013

CLINICAL PHARMACOLOGY

Microbiology

Mechanism of Action:

The mechanism of action of ciclopirox has been investigated using various in vitro and in vivo infection models. One in vitro study suggested that ciclopirox acts by chelation of polyvalent cations (Fe+ 3 or Al+ 3) resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell. The clinical significance of this observation is not known.

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Ciclopirox - FDA Drug Approval Details