Ciclopirox

Product NDC
72162-1321
11-digit product format
721621321
Labeler code
72162
Product ID
72162-1321_92ecd320-2cb7-4f97-97fa-c02f56fd3097
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Bryant Ranch Prepack
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
72162-1321-2Ciclopirox1 in 1 CARTONSOLUTION1100
72162-1321-2Ciclopirox6.6 mL in 1 BOTTLESOLUTION6.6100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1321-2ML - Milliliter72162-1321bb757174-6d8f-455a-9e5c-07157bff25cf12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1321CICLOPIROX SOLUTION [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20240322_aaa27021-68a6-486c-9095-56de1140ca2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309291ciclopirox 8 % Topical SolutionPSNaaa27021-68a6-486c-9095-56de1140ca2d100
309291ciclopirox 80 MG/ML Topical SolutionSCDaaa27021-68a6-486c-9095-56de1140ca2d100
309291ciclopirox 8 % (nail lacquer) Topical SolutionSYaaa27021-68a6-486c-9095-56de1140ca2d100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1321-2721621321021 BOTTLE in 1 CARTON (72162-1321-2) / 6.6 mL in 1 BOTTLE1 bottle2024-03-21NoNoCurrent