Ciclopirox olamine

Product NDC
71335-2865
11-digit product format
713352865
Labeler code
71335
Product ID
71335-2865_c777ce05-5026-460d-964f-b6b3faaf781d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox olamine
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA077364
Marketing category
ANDA
Marketing start
2006-07-19
Substance
CICLOPIROX OLAMINE
Active strength
7.7 mg/g
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
71335-2865-1713352865011 TUBE in 1 CARTON (71335-2865-1) / 15 g in 1 TUBE1 tube2025-10-24NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ciclopirox Olamine Cream USP, 0.77%Bryant Ranch Prepack2025-10-24HUMAN PRESCRIPTION DRUG LABEL100