Ciclopirox Olamine

Product NDC
72162-1406
11-digit product format
721621406
Labeler code
72162
Product ID
72162-1406_bd13e41b-98e8-41f4-af32-10df498f93cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox Olamine
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA077676
Marketing category
ANDA
Marketing start
2006-12-29
Substance
CICLOPIROX OLAMINE
Active strength
7.7 mg/100mL
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
50MD4SB4APCICLOPIROX OLAMINE41621-49-2CICLOPIROX OLAMINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1406-3721621406031 BOTTLE in 1 CARTON (72162-1406-3) / 30 mL in 1 BOTTLE1 bottle2023-10-02NoNoHistorical
72162-1406-6721621406061 BOTTLE in 1 CARTON (72162-1406-6) / 60 mL in 1 BOTTLE1 bottle2023-10-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) (Lotion) Rx OnlyBryant Ranch Prepack2024-12-24HUMAN PRESCRIPTION DRUG LABEL103