Ciclopirox

Product NDC
61360-1351
11-digit product format
613601351
Labeler code
61360
Product ID
61360-1351_9880db7c-4fdf-42b4-b415-67c224f7838a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciclopirox
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Taro Pharmaceuticals, Inc.
Application
ANDA090269
Marketing category
ANDA
Marketing start
2011-02-23
Marketing end
0000-00-00
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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61360-1351-82020-01-31C16284748780-19d75b9cf-d9b5-f424-e053-dadaa90a57ceCiclopirox Shampoo, 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61360-1351-8Ciclopirox120 mL in 1 BOTTLE, PLASTICSHAMPOO1201
61360-1351-8Ciclopirox1 in 1 CARTONSHAMPOO11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ciclopiroxACTIVE INGREDIENT19W019ZDRJCICLOPIROX SHAMPOO [TARO PHARMACEUTICALS, INC.]1
ciclopiroxACTIVE MOIETY19W019ZDRJCICLOPIROX SHAMPOO [TARO PHARMACEUTICALS, INC.]1
disodium laureth sulfosuccinateINACTIVE INGREDIENTD6DH1DTN7ECICLOPIROX SHAMPOO [TARO PHARMACEUTICALS, INC.]1
laureth-2INACTIVE INGREDIENTD4D38LT1L5CICLOPIROX SHAMPOO [TARO PHARMACEUTICALS, INC.]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XCICLOPIROX SHAMPOO [TARO PHARMACEUTICALS, INC.]1
sodium laureth sulfateINACTIVE INGREDIENTBPV390UAP0CICLOPIROX SHAMPOO [TARO PHARMACEUTICALS, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RCICLOPIROX SHAMPOO [TARO PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61360-1351CICLOPIROX SHAMPOO [TARO PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20111123_46af5d52-db81-4b87-b5c4-80d8416fc1c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
250344ciclopirox 1 % Medicated ShampooPSN46af5d52-db81-4b87-b5c4-80d8416fc1c31
250344ciclopirox 10 MG/ML Medicated ShampooSCD46af5d52-db81-4b87-b5c4-80d8416fc1c31
250344ciclopirox 1 % Medicated ShampooSY46af5d52-db81-4b87-b5c4-80d8416fc1c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
61360-1351-861360135108120 mL in 1 BOTTLE, PLASTIC120 mlHistorical