Ciclopirox

Product NDC
51672-5302
11-digit product format
516725302
Labeler code
51672
Product ID
51672-5302_750328ca-20f2-44db-8f03-54eb82582b8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciclopirox
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA078233
Marketing category
ANDA
Marketing start
2016-04-04
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
No
Listing certified through
2020-12-31
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
51672-5302-02025-01-30C16284748780-12cef2736-b528-d83d-e063-dadaa90ab31fCiclopirox Topical Solution, 8% (Nail Lacquer)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-5302-0Ciclopirox1 in 1 CARTONSOLUTION13
51672-5302-0Ciclopirox6.6 mL in 1 BOTTLE, WITH APPLICATORSOLUTION6.63

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-5302-0ML - Milliliter51672-530267334432-568c-45b7-8dfd-93a21b00e9e012016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-5302CICLOPIROX SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]3Legacy NDC, 2 package rows20191219_9144c51a-5a76-43b9-958d-c0d9fd4269e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309291ciclopirox 8 % Topical SolutionPSN9144c51a-5a76-43b9-958d-c0d9fd4269e53
309291ciclopirox 80 MG/ML Topical SolutionSCD9144c51a-5a76-43b9-958d-c0d9fd4269e53
309291ciclopirox 8 % (nail lacquer) Topical SolutionSY9144c51a-5a76-43b9-958d-c0d9fd4269e53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51672-5302-0516725302001 BOTTLE, WITH APPLICATOR in 1 CARTON (51672-5302-0) > 6.6 mL in 1 BOTTLE, WITH APPLICATOR2016-04-040000-00-00NoNoCurrent