FDA.reportPublic FDA data

Ciclopirox

Product NDC
63629-8623
11-digit product format
636298623
Labeler code
63629
Product ID
63629-8623_00b59586-8858-c5ba-e063-6294a90af650
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA077623
Marketing category
ANDA
Marketing start
2007-09-19
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ciclopirox
Listing expiration
2026-12-31

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
63629-8623-1Ciclopirox6.6 mL in 1 BOTTLE, WITH APPLICATORSOLUTION6.6102
63629-8623-1Ciclopirox1 in 1 CARTONSOLUTION1102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8623-1ML - Milliliter63629-86232f5bf8d3-4919-45d8-b819-a1434bcb4dfe12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8623CICLOPIROX SOLUTION [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 2 package rows20230718_9c7d1fd9-71dd-4bbb-aed2-7db5cffa8b5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309291ciclopirox 8 % Topical SolutionPSN9c7d1fd9-71dd-4bbb-aed2-7db5cffa8b5a102
309291ciclopirox 80 MG/ML Topical SolutionSCD9c7d1fd9-71dd-4bbb-aed2-7db5cffa8b5a102
309291ciclopirox 8 % (nail lacquer) Topical SolutionSY9c7d1fd9-71dd-4bbb-aed2-7db5cffa8b5a102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8623-1636298623011 BOTTLE, WITH APPLICATOR in 1 CARTON (63629-8623-1) / 6.6 mL in 1 BOTTLE, WITH APPLICATOR2021-07-090000-00-00NoNoCurrent