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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CICLOPIROX OLAMINE7.7 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii50MD4SB4AP
Rxcui309290

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d24c6245-86b5-4444-bc75-c1ac73ab3016Product name120180612
c7015f08-288e-4cfa-93b5-f4959a4814aeProduct name120150324
3f974526-143f-9d19-ee0c-98eeee0cdc3fProduct name120140508
5c035cac-559a-7171-c5cb-f0bd0d0fbc86Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2915-1Ciclopirox Olamine1 in 1 CARTONSUSPENSION1100
71335-2915-1Ciclopirox Olamine30 mL in 1 BOTTLESUSPENSION30100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2915-1ML - Milliliter71335-2915bf06bf4d-6664-487b-a31e-57760c4e81d312026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309290ciclopirox 0.77 % Topical LotionPSN835a6370-f331-4b15-b6fa-beafe027f187100
309290ciclopirox 7.7 MG/ML Topical LotionSCD835a6370-f331-4b15-b6fa-beafe027f187100
309290ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical LotionSY835a6370-f331-4b15-b6fa-beafe027f187100
309290ciclopirox 0.77 % Topical LotionSY835a6370-f331-4b15-b6fa-beafe027f187100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2915-1713352915011 BOTTLE in 1 CARTON (71335-2915-1) / 30 mL in 1 BOTTLE1 bottle2025-10-24NoNoCurrent