Ciclopirox
Ciclopirox Topical Solution, 8%
Approved
Approval ID
d7e22682-1485-47e5-b6ae-94534bd3d889
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 16, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code72162-2076
Application NumberANDA077623
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciclopirox
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 17, 2023
FDA Product Classification
INGREDIENTS (3)
ETHYL ACETATEInactive
Code: 76845O8NMZ
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
CICLOPIROXActive
Quantity: 80 mg in 1 mL
Code: 19W019ZDRJ
Classification: ACTIB
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 1/24/2023
Gantrez® is a registered trademark of GAF Corporation.