Ciclopirox

Product NDC
50090-6562
11-digit product format
500906562
Labeler code
50090
Product ID
50090-6562_68e187e9-f915-4585-bfcc-c78fb13cd75f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox
Dosage form
SOLUTION
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA078172
Marketing category
ANDA
Marketing start
2019-11-04
Substance
CICLOPIROX
Active strength
80 mg/mL
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CICLOPIROX80 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19W019ZDRJ
Rxcui309291

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
50090-6562-0Ciclopirox6.6 mL in 1 BOTTLESOLUTION6.63
50090-6562-0Ciclopirox1 in 1 CARTONSOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6562CICLOPIROX SOLUTION [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20230722_b281493f-ce8c-42f8-95c7-2eb1c9712157.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309291ciclopirox 8 % Topical SolutionPSNb281493f-ce8c-42f8-95c7-2eb1c97121573
309291ciclopirox 80 MG/ML Topical SolutionSCDb281493f-ce8c-42f8-95c7-2eb1c97121573
309291ciclopirox 8 % (nail lacquer) Topical SolutionSYb281493f-ce8c-42f8-95c7-2eb1c97121573

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6562-0500906562001 BOTTLE in 1 CARTON (50090-6562-0) / 6.6 mL in 1 BOTTLE1 bottle2023-07-18NoNoCurrent