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

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/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii50MD4SB4AP
Rxcui309289

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2865-1Ciclopirox olamine1 in 1 CARTONCREAM1100
71335-2865-1Ciclopirox olamine15 g in 1 TUBECREAM15100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2865-1GM - Gram71335-28659b47474a-4561-494e-8a3e-9492025e8e3112025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309289ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical CreamPSN43a7cab8-7921-43bd-8bfa-a9b96f97c94b100
309289ciclopirox 7.7 MG/ML Topical CreamSCD43a7cab8-7921-43bd-8bfa-a9b96f97c94b100
309289ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical CreamSY43a7cab8-7921-43bd-8bfa-a9b96f97c94b100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2865-1713352865011 TUBE in 1 CARTON (71335-2865-1) / 15 g in 1 TUBE1 tube2025-10-24NoNoCurrent