CNL8

Product NDC
68712-027
11-digit product format
687120027
Labeler code
68712
Product ID
68712-027_b367ac0c-2c88-4c37-809b-da4297a47cc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Innocutis Holdings LLC
Application
ANDA078270
Marketing category
ANDA
Marketing start
2008-10-31
Marketing end
0000-00-00
Substance
CICLOPIROX
Active strength
2 g/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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68712-027-01CNL83 in 1 CARTONSOLUTION33
68712-027-03CNL85 mL in 1 BOTTLE, GLASSSOLUTION53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68712-027CNL8 (CICLOPIROX ) SOLUTION [INNOCUTIS HOLDINGS LLC]3Legacy NDC, 2 package rows20111219_68955ba2-590f-4460-994e-bc481aed3d23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309291ciclopirox 8 % Topical SolutionPSN68955ba2-590f-4460-994e-bc481aed3d233
847217cnl8 8 % Topical SolutionPSN68955ba2-590f-4460-994e-bc481aed3d233
847217ciclopirox 80 MG/ML Topical Solution [CNL8]SBD68955ba2-590f-4460-994e-bc481aed3d233
309291ciclopirox 80 MG/ML Topical SolutionSCD68955ba2-590f-4460-994e-bc481aed3d233
309291ciclopirox 8 % (nail lacquer) Topical SolutionSY68955ba2-590f-4460-994e-bc481aed3d233
847217CNL8 8 % Topical SolutionSY68955ba2-590f-4460-994e-bc481aed3d233
847217CNL8 80 MG/ML Topical SolutionSY68955ba2-590f-4460-994e-bc481aed3d233

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68712-027-01687120027013 in 1 CARTONHistorical
68712-027-03687120027035 mL in 1 BOTTLE, GLASS5 mlHistorical