Ciclopirox

Product NDC
21695-475
11-digit product format
216950475
Labeler code
21695
Product ID
21695-475_70429bdd-af83-4345-99d5-54fde6f28e5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Rebel Distributors Corp.
Application
ANDA078270
Marketing category
ANDA
Marketing start
2007-09-18
Marketing end
0000-00-00
Substance
CICLOPIROX
Active strength
71 mg/mL
Pharmacologic classes
Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-475-662019-09-24C16284748780-1934fe258-4824-48b1-e053-8cdaa90a720aCiclopirox Topical Solution, 8% (Nail Lacquer)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-475-66Ciclopirox6.6 mL in 1 BOTTLESOLUTION6.61

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-475-66ML - Milliliter21695-475863ace9d-e4fe-4025-8737-eaa5d6c7b46f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CICLOPIROXACTIVE INGREDIENT19W019ZDRJCICLOPIROX SOLUTION [REBEL DISTRIBUTORS CORP.]1
CICLOPIROXACTIVE MOIETY19W019ZDRJCICLOPIROX SOLUTION [REBEL DISTRIBUTORS CORP.]1
ETHYL ACETATEINACTIVE INGREDIENT76845O8NMZCICLOPIROX SOLUTION [REBEL DISTRIBUTORS CORP.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CICLOPIROX SOLUTION [REBEL DISTRIBUTORS CORP.]1
MALEIC ACIDINACTIVE INGREDIENT91XW058U2CCICLOPIROX SOLUTION [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-475CICLOPIROX SOLUTION [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20091216_ee775b56-0575-41e4-a948-c92a0bcd69b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309291ciclopirox 8 % Topical SolutionPSNee775b56-0575-41e4-a948-c92a0bcd69b61
309291ciclopirox 80 MG/ML Topical SolutionSCDee775b56-0575-41e4-a948-c92a0bcd69b61
309291ciclopirox 8 % (nail lacquer) Topical SolutionSYee775b56-0575-41e4-a948-c92a0bcd69b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-475-66216950475666.6 mL in 1 BOTTLE6.6 mlHistorical