Ciclopirox

Product NDC
62135-814
11-digit product format
621350814
Labeler code
62135
Product ID
62135-814_41b5be9e-4f27-f7aa-e063-6394a90a00d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Chartwell RX, LLC
Application
ANDA078046
Marketing category
ANDA
Marketing start
2007-09-18
Substance
CICLOPIROX
Active strength
71.3 mg/mL
Pharmacologic classes
Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
19W019ZDRJCICLOPIROX29342-05-0CICLOPIROX

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-814-45621350814456.6 mL in 1 BOTTLE (62135-814-45) 6.6 ml2024-03-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CiclopiroxChartwell RX, LLC2025-10-21HUMAN PRESCRIPTION DRUG LABEL2
CiclopiroxChartwell RX, LLC2024-04-04HUMAN PRESCRIPTION DRUG LABEL1