FDA.reportPublic FDA data

CICLOPIROX

Product NDC
61748-200
11-digit product format
617480200
Labeler code
61748
Product ID
61748-200_2bc21396-13d3-4e4a-8260-153f4e2c15f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CICLOPIROX
Dosage form
SOLUTION
Route
TOPICAL
Labeler
VersaPharm Incorporated
Application
ANDA078975
Marketing category
ANDA
Marketing start
2010-03-20
Marketing end
0000-00-00
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
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
61748-200-062020-01-31C16284748780-19d75b9d0-92d1-f424-e053-dadaa90a57ceCiclopirox Topical Solution, 8% (Nail Lacquer)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61748-200-06CICLOPIROX6.6 mL in 1 BOTTLE, WITH APPLICATORSOLUTION6.63

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61748-200-06ML - Milliliter61748-2009c9d0f17-2bac-4c4a-a661-43fcc9da20aa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CICLOPIROXACTIVE INGREDIENT19W019ZDRJCICLOPIROX SOLUTION [VERSAPHARM INCORPORATED]3
CICLOPIROXACTIVE MOIETY19W019ZDRJCICLOPIROX SOLUTION [VERSAPHARM INCORPORATED]3
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW)INACTIVE INGREDIENT389H2R62BDCICLOPIROX SOLUTION [VERSAPHARM INCORPORATED]3
ETHYL ACETATEINACTIVE INGREDIENT76845O8NMZCICLOPIROX SOLUTION [VERSAPHARM INCORPORATED]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CICLOPIROX SOLUTION [VERSAPHARM INCORPORATED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61748-200CICLOPIROX SOLUTION [VERSAPHARM INCORPORATED]3Legacy NDC, 1 package rows20141113_5a562e2c-ac56-4e83-89b0-fe625e4c5e1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309291ciclopirox 8 % Topical SolutionPSN5a562e2c-ac56-4e83-89b0-fe625e4c5e1d3
309291ciclopirox 80 MG/ML Topical SolutionSCD5a562e2c-ac56-4e83-89b0-fe625e4c5e1d3
309291ciclopirox 8 % (nail lacquer) Topical SolutionSY5a562e2c-ac56-4e83-89b0-fe625e4c5e1d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
61748-200-06617480200066.6 mL in 1 BOTTLE, WITH APPLICATOR6.6 mlHistorical