FDA.reportPublic FDA data

Ciclopirox

Product NDC
45802-141
11-digit product format
458020141
Labeler code
45802
Product ID
45802-141_d75239bb-7620-45a8-9c3b-a41e4baa48dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA077623
Marketing category
ANDA
Marketing start
2007-09-19
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
45802-141-67Ciclopirox1 in 1 CARTONSOLUTION18
45802-141-67Ciclopirox6.6 mL in 1 BOTTLE, WITH APPLICATORSOLUTION6.68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-141-67ML - Milliliter45802-141bf8903c7-a0b9-4086-9835-1dbed327b94612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CICLOPIROXACTIVE INGREDIENT19W019ZDRJCICLOPIROX SOLUTION [PERRIGO NEW YORK INC]2
CICLOPIROXACTIVE MOIETY19W019ZDRJCICLOPIROX SOLUTION [PERRIGO NEW YORK INC]2
ETHYL ACETATEINACTIVE INGREDIENT76845O8NMZCICLOPIROX SOLUTION [PERRIGO NEW YORK INC]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CICLOPIROX SOLUTION [PERRIGO NEW YORK INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-141CICLOPIROX SOLUTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]7Current NDC, Legacy NDC, 2 package rows20230125_02f46b6e-b424-4210-83bf-e79618df4344.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309291ciclopirox 8 % Topical SolutionPSN9c7d1fd9-71dd-4bbb-aed2-7db5cffa8b5a102
309291ciclopirox 80 MG/ML Topical SolutionSCD9c7d1fd9-71dd-4bbb-aed2-7db5cffa8b5a102
309291ciclopirox 8 % (nail lacquer) Topical SolutionSY9c7d1fd9-71dd-4bbb-aed2-7db5cffa8b5a102
309291ciclopirox 8 % Topical SolutionPSNd7e22682-1485-47e5-b6ae-94534bd3d889101
309291ciclopirox 80 MG/ML Topical SolutionSCDd7e22682-1485-47e5-b6ae-94534bd3d889101
309291ciclopirox 8 % (nail lacquer) Topical SolutionSYd7e22682-1485-47e5-b6ae-94534bd3d889101
309291ciclopirox 8 % Topical SolutionPSNefcd78c0-2426-4fcc-a1c8-527e4e6f99d310
309291ciclopirox 80 MG/ML Topical SolutionSCDefcd78c0-2426-4fcc-a1c8-527e4e6f99d310
309291ciclopirox 8 % (nail lacquer) Topical SolutionSYefcd78c0-2426-4fcc-a1c8-527e4e6f99d310
309291ciclopirox 8 % Topical SolutionPSN02f46b6e-b424-4210-83bf-e79618df43448
309291ciclopirox 80 MG/ML Topical SolutionSCD02f46b6e-b424-4210-83bf-e79618df43448
309291ciclopirox 8 % (nail lacquer) Topical SolutionSY02f46b6e-b424-4210-83bf-e79618df43448

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45802-141-67458020141671 BOTTLE, WITH APPLICATOR in 1 CARTON (45802-141-67) / 6.6 mL in 1 BOTTLE, WITH APPLICATOR2007-09-190000-00-00NoNoCurrent