Ciclopirox Olamine

Product NDC
68258-3996
11-digit product format
682583996
Labeler code
68258
Product ID
68258-3996_6b02cebe-eea9-464f-88eb-7c9db13b79fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox Olamine
Dosage form
CREAM
Route
TOPICAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA090273
Marketing category
ANDA
Marketing start
2009-11-13
Marketing end
0000-00-00
Substance
CICLOPIROX OLAMINE
Active strength
8 mg/g
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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d24c6245-86b5-4444-bc75-c1ac73ab3016Product name120180612
c7015f08-288e-4cfa-93b5-f4959a4814aeProduct name120150324
3f974526-143f-9d19-ee0c-98eeee0cdc3fProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
5c035cac-559a-7171-c5cb-f0bd0d0fbc86Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68258-3996-32019-11-27C16284748780-19855d018-de92-cd31-e053-dbdaa90ab51aCiclopirox Olamine Cream USP, 0.77%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-3996-3Ciclopirox Olamine30 g in 1 CARTONCREAM303

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-3996CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.]3Legacy NDC, 1 package rows20121004_9982d093-9f17-48de-8d06-b8256a20c764.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309289ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical CreamPSN9982d093-9f17-48de-8d06-b8256a20c7643
309289ciclopirox 7.7 MG/ML Topical CreamSCD9982d093-9f17-48de-8d06-b8256a20c7643
309289ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical CreamSY9982d093-9f17-48de-8d06-b8256a20c7643

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68258-3996-36825839960330 g in 1 CARTON30 gHistorical