Ciclopirox

Product NDC
0591-2159
11-digit product format
005912159
Labeler code
0591
Product ID
0591-2159_7c6bdb3d-4717-429d-9632-3f64d7aa2e80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
ANDA090490
Marketing category
ANDA
Marketing start
2012-12-12
Substance
CICLOPIROX
Active strength
10 mg/.96mL
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
CICLOPIROX10 mg/.96mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19W019ZDRJ
Rxcui250344

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
0591-2159-90Ciclopirox120 mL in 1 BOTTLE, PLASTICSHAMPOO12023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2159-90ML - Milliliter0591-21591745fbfe-afab-428c-bea4-476aa05251c712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CICLOPIROXACTIVE INGREDIENT19W019ZDRJCICLOPIROX SHAMPOO [WATSON LABORATORIES, INC.]13
CICLOPIROXACTIVE MOIETY19W019ZDRJCICLOPIROX SHAMPOO [WATSON LABORATORIES, INC.]13
DISODIUM LAURETH SULFOSUCCINATEINACTIVE INGREDIENTD6DH1DTN7ECICLOPIROX SHAMPOO [WATSON LABORATORIES, INC.]13
LAURETH-2INACTIVE INGREDIENTD4D38LT1L5CICLOPIROX SHAMPOO [WATSON LABORATORIES, INC.]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCICLOPIROX SHAMPOO [WATSON LABORATORIES, INC.]13
SODIUM LAURETH-3 SULFATEINACTIVE INGREDIENTBPV390UAP0CICLOPIROX SHAMPOO [WATSON LABORATORIES, INC.]13
WATERINACTIVE INGREDIENT059QF0KO0RCICLOPIROX SHAMPOO [WATSON LABORATORIES, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2159CICLOPIROX SHAMPOO [ACTAVIS PHARMA, INC.]23Current NDC, Legacy NDC, 1 package rows20240331_eef13684-751f-47e1-b75e-3401a0e6e20f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
250344ciclopirox 1 % Medicated ShampooPSNeef13684-751f-47e1-b75e-3401a0e6e20f23
250344ciclopirox 10 MG/ML Medicated ShampooSCDeef13684-751f-47e1-b75e-3401a0e6e20f23
250344ciclopirox 1 % Medicated ShampooSYeef13684-751f-47e1-b75e-3401a0e6e20f23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-2159-9000591215990120 mL in 1 BOTTLE, PLASTIC (0591-2159-90) 120 ml2012-12-120000-00-00NoNoCurrent