FDA.reportPublic FDA data

Ciclodan

Product NDC
43538-500
11-digit product format
435380500
Labeler code
43538
Product ID
43538-500_9e5c8888-85f4-4f9c-b807-b30e66a3c4a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciclopirox
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Medimetriks Pharmaceuticals, Inc.
Application
ANDA078233
Marketing category
ANDA
Marketing start
2011-04-10
Marketing end
0000-00-00
Substance
CICLOPIROX
Active strength
2 g/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
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43538-500-062025-01-30C16284748780-12cef2736-86ba-d83d-e063-dadaa90ab31fCiclodan ® Ciclopirox Topical Solution, 8% (Nail Lacquer)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43538-500-06Ciclodan6.6 mL in 1 BOTTLE, WITH APPLICATORSOLUTION6.65

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43538-500-06ML - Milliliter43538-50063a4bf23-70da-4588-97cc-082cdf2e84e912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ciclopiroxACTIVE INGREDIENT19W019ZDRJCICLODAN (CICLOPIROX) SOLUTION [MEDIMETRIKS PHARMACEUTICALS, INC.]1
ciclopiroxACTIVE MOIETY19W019ZDRJCICLODAN (CICLOPIROX) SOLUTION [MEDIMETRIKS PHARMACEUTICALS, INC.]1
butyl ester of methyl vinyl ether-maleic anhydride copolymer (125 kd)INACTIVE INGREDIENT389H2R62BDCICLODAN (CICLOPIROX) SOLUTION [MEDIMETRIKS PHARMACEUTICALS, INC.]1
ethyl acetateINACTIVE INGREDIENT76845O8NMZCICLODAN (CICLOPIROX) SOLUTION [MEDIMETRIKS PHARMACEUTICALS, INC.]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302CICLODAN (CICLOPIROX) SOLUTION [MEDIMETRIKS PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43538-500CICLODAN (CICLOPIROX) SOLUTION [MEDIMETRIKS PHARMACEUTICALS, INC.]5Legacy NDC, 1 package rows20201224_246676e5-60a0-41dc-b665-30d5e670b426.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100057Ciclodan 8 % (Nail Lacquer) Topical SolutionPSN246676e5-60a0-41dc-b665-30d5e670b4265
309291ciclopirox 8 % Topical SolutionPSN246676e5-60a0-41dc-b665-30d5e670b4265
1100057ciclopirox 80 MG/ML Topical Solution [Ciclodan]SBD246676e5-60a0-41dc-b665-30d5e670b4265
309291ciclopirox 80 MG/ML Topical SolutionSCD246676e5-60a0-41dc-b665-30d5e670b4265
1100057Ciclodan 8 % Topical SolutionSY246676e5-60a0-41dc-b665-30d5e670b4265
1100057Ciclodan 80 MG/ML Topical SolutionSY246676e5-60a0-41dc-b665-30d5e670b4265
309291ciclopirox 8 % (nail lacquer) Topical SolutionSY246676e5-60a0-41dc-b665-30d5e670b4265

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43538-500-06435380500066.6 mL in 1 BOTTLE, WITH APPLICATOR (43538-500-06) 6.6 ml2011-04-100000-00-00NoNoCurrent