CICLOPIROX

Product NDC
72162-2298
11-digit product format
721622298
Labeler code
72162
Product ID
72162-2298_d416f5e5-641b-44ab-8aa7-401027822b52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciclopirox
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA077687
Marketing category
ANDA
Marketing start
2023-11-09
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
72162-2298-2CICLOPIROX1 in 1 CARTONSOLUTION1103
72162-2298-2CICLOPIROX6.6 mL in 1 BOTTLE, WITH APPLICATORSOLUTION6.6103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2298-2ML - Milliliter72162-22988ab863e4-8f7b-4688-b9e1-16b6379495cf12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2298CICLOPIROX SOLUTION [BRYANT RANCH PREPACK]102Current NDC, 2 package rows20241116_f3e0ea78-42c0-4430-b299-fffee9e09c16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309291ciclopirox 8 % Topical SolutionPSNf3e0ea78-42c0-4430-b299-fffee9e09c16103
309291ciclopirox 80 MG/ML Topical SolutionSCDf3e0ea78-42c0-4430-b299-fffee9e09c16103
309291ciclopirox 8 % (nail lacquer) Topical SolutionSYf3e0ea78-42c0-4430-b299-fffee9e09c16103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2298-2721622298021 BOTTLE, WITH APPLICATOR in 1 CARTON (72162-2298-2) / 6.6 mL in 1 BOTTLE, WITH APPLICATOR2023-11-09NoNoHistorical