Ciclopirox Olamine

Product NDC
71335-2915
11-digit product format
713352915
Labeler code
71335
Product ID
71335-2915_60371a57-545f-458b-8ca1-016eb9b78629
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

Additional Listing Data

Finished product
Yes
Brand name base
Ciclopirox Olamine
Listing expiration
2026-12-31

Related Records

Active Ingredients

IngredientStrength
CICLOPIROX OLAMINE7.7 mg/100mL

Harmonized Identifiers

FieldValues
Unii50MD4SB4AP
Rxcui309290

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
50MD4SB4APCICLOPIROX OLAMINE41621-49-2CICLOPIROX OLAMINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2915-1713352915011 BOTTLE in 1 CARTON (71335-2915-1) / 30 mL in 1 BOTTLE1 bottle2025-10-24NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) (Lotion)Bryant Ranch Prepack2025-10-24HUMAN PRESCRIPTION DRUG LABEL100