Ciclopirox

Product NDC
45802-401
11-digit product format
458020401
Labeler code
45802
Product ID
45802-401_f9c45e64-a8ae-4bc5-9d1f-40eac9847c55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA078594
Marketing category
ANDA
Marketing start
2010-02-17
Substance
CICLOPIROX
Active strength
1 g/100mL
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
CICLOPIROX1 g/100mL

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
45802-401-09Ciclopirox120 mL in 1 BOTTLESHAMPOO12010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-401-09ML - Milliliter45802-40112414b79-1170-4a8e-8f70-b349b1b4f95d12012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-401CICLOPIROX SHAMPOO [PADAGIS ISRAEL PHARMACEUTICALS LTD]9Current NDC, Legacy NDC, 1 package rows20240302_c3722d52-407c-499b-a08b-b299609f203c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
250344ciclopirox 1 % Medicated ShampooPSNc3722d52-407c-499b-a08b-b299609f203c10
250344ciclopirox 10 MG/ML Medicated ShampooSCDc3722d52-407c-499b-a08b-b299609f203c10
250344ciclopirox 1 % Medicated ShampooSYc3722d52-407c-499b-a08b-b299609f203c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-401-0945802040109120 mL in 1 BOTTLE (45802-401-09) 120 ml2010-02-170000-00-00NoNoCurrent