CICLOPIROX

Product NDC
71335-2836
11-digit product format
713352836
Labeler code
71335
Product ID
71335-2836_aa26cf31-7dfe-4454-9d18-53ecd28dbc15
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
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
71335-2836-1CICLOPIROX1 in 1 CARTONSOLUTION1100
71335-2836-1CICLOPIROX6.6 mL in 1 BOTTLE, WITH APPLICATORSOLUTION6.6100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2836-1ML - Milliliter71335-2836677b094b-5ce0-4538-934d-110c1f8a2daa12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309291ciclopirox 8 % Topical SolutionPSN1548af93-0dc1-4606-865f-6201b2bb7de1100
309291ciclopirox 80 MG/ML Topical SolutionSCD1548af93-0dc1-4606-865f-6201b2bb7de1100
309291ciclopirox 8 % (nail lacquer) Topical SolutionSY1548af93-0dc1-4606-865f-6201b2bb7de1100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2836-1713352836011 BOTTLE, WITH APPLICATOR in 1 CARTON (71335-2836-1) / 6.6 mL in 1 BOTTLE, WITH APPLICATOR2025-10-22NoNoCurrent