Ciclopirox

Product NDC
51672-1351
11-digit product format
516721351
Labeler code
51672
Product ID
51672-1351_39620da3-e63e-e94f-e063-6294a90afd69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciclopirox
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090269
Marketing category
ANDA
Marketing start
2011-02-23
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

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
51672-1351-8Ciclopirox1 in 1 CARTONSHAMPOO18
51672-1351-8Ciclopirox120 mL in 1 BOTTLE, PLASTICSHAMPOO1208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1351-8ML - Milliliter51672-135139234458-8bf0-4caa-83f5-daf4194792ed12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ciclopiroxACTIVE INGREDIENT19W019ZDRJCICLOPIROX SHAMPOO [TARO PHARMACEUTICALS U.S.A., INC.]4
ciclopiroxACTIVE MOIETY19W019ZDRJCICLOPIROX SHAMPOO [TARO PHARMACEUTICALS U.S.A., INC.]4
disodium laureth sulfosuccinateINACTIVE INGREDIENTD6DH1DTN7ECICLOPIROX SHAMPOO [TARO PHARMACEUTICALS U.S.A., INC.]4
laureth-2INACTIVE INGREDIENTD4D38LT1L5CICLOPIROX SHAMPOO [TARO PHARMACEUTICALS U.S.A., INC.]4
sodium chlorideINACTIVE INGREDIENT451W47IQ8XCICLOPIROX SHAMPOO [TARO PHARMACEUTICALS U.S.A., INC.]4
sodium laureth-3 sulfateINACTIVE INGREDIENTBPV390UAP0CICLOPIROX SHAMPOO [TARO PHARMACEUTICALS U.S.A., INC.]4
waterINACTIVE INGREDIENT059QF0KO0RCICLOPIROX SHAMPOO [TARO PHARMACEUTICALS U.S.A., INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1351CICLOPIROX SHAMPOO [TARO PHARMACEUTICALS U.S.A., INC.]7Current NDC, Legacy NDC, 2 package rows20241222_b44b190b-8e2a-4937-a6c5-92f37911e7f8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51672-1351-8516721351081 BOTTLE, PLASTIC in 1 CARTON (51672-1351-8) / 120 mL in 1 BOTTLE, PLASTIC2011-02-230000-00-00NoNoCurrent