CICLOPIROX OLAMINE

Product NDC
69315-309
11-digit product format
693150309
Labeler code
69315
Product ID
69315-309_232bf664-5638-47a3-a464-440467039140
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CICLOPIROX OLAMINE
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
Leading Pharma, LLC
Application
NDA019824
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-12-01
Marketing end
0000-00-00
Substance
CICLOPIROX OLAMINE
Active strength
8 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
2021-12-31
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69315-309-30CICLOPIROX OLAMINE30 mL in 1 BOTTLESUSPENSION302
69315-309-60CICLOPIROX OLAMINE60 mL in 1 BOTTLESUSPENSION602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-309-30ML - Milliliter69315-30943179261-c9bc-400c-8ad0-2c6fadcf687f12019-04-11
69315-309-60ML - Milliliter69315-309fa7bc610-e028-44dc-bf62-d80864436d7e12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-309CICLOPIROX OLAMINE SUSPENSION [LEADING PHARMA, LLC]2Legacy NDC, 2 package rows20201218_370ab878-2753-435f-ae06-67ec9f9502e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309290ciclopirox 0.77 % Topical LotionPSN370ab878-2753-435f-ae06-67ec9f9502e12
309290ciclopirox 7.7 MG/ML Topical LotionSCD370ab878-2753-435f-ae06-67ec9f9502e12
309290ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical LotionSY370ab878-2753-435f-ae06-67ec9f9502e12
309290ciclopirox 0.77 % Topical LotionSY370ab878-2753-435f-ae06-67ec9f9502e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69315-309-306931503093030 mL in 1 BOTTLE (69315-309-30) 30 ml2019-02-250000-00-00NoNoCurrent
69315-309-606931503096060 mL in 1 BOTTLE (69315-309-60) 60 ml2019-02-250000-00-00NoNoCurrent