FDA.reportPublic FDA data

Ciclopirox

Product NDC
68788-6797
11-digit product format
687886797
Labeler code
68788
Product ID
68788-6797_d8e8b3d5-07e7-4b46-994a-b642ecf947ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA077623
Marketing category
ANDA
Marketing start
2016-11-03
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ciclopirox
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CICLOPIROX80 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19W019ZDRJ
Rxcui309291

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-6797-6Ciclopirox6.6 mL in 1 BOTTLE, WITH APPLICATORSOLUTION6.610
68788-6797-6Ciclopirox1 in 1 CARTONSOLUTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-6797-6ML - Milliliter68788-67975a4c1fdd-722e-46a2-972e-6d10df11f28012024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-6797CICLOPIROX SOLUTION [PREFERRED PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 2 package rows20250302_efcd78c0-2426-4fcc-a1c8-527e4e6f99d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309291ciclopirox 8 % Topical SolutionPSNefcd78c0-2426-4fcc-a1c8-527e4e6f99d310
309291ciclopirox 80 MG/ML Topical SolutionSCDefcd78c0-2426-4fcc-a1c8-527e4e6f99d310
309291ciclopirox 8 % (nail lacquer) Topical SolutionSYefcd78c0-2426-4fcc-a1c8-527e4e6f99d310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-6797-6687886797061 BOTTLE, WITH APPLICATOR in 1 CARTON (68788-6797-6) / 6.6 mL in 1 BOTTLE, WITH APPLICATOR2016-11-030000-00-00NoNoCurrent