CICLOPIROX

Product NDC
21922-105
11-digit product format
219220105
Labeler code
21922
Product ID
21922-105_1b7b23aa-fc6d-4b37-b5db-7fd7bc994bf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciclopirox
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA209975
Marketing category
ANDA
Marketing start
2025-12-03
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CICLOPIROX
Listing expiration
2027-12-31

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
21922-105-52CICLOPIROX120 mL in 1 BOTTLESHAMPOO1201
21922-105-52CICLOPIROX1 in 1 CARTONSHAMPOO11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-105-52ML - Milliliter21922-105cefdefee-75da-47cf-8132-1e86a16eea1812026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
250344ciclopirox 1 % Medicated ShampooPSNcb456f2e-6645-4cc4-8e71-299c47ccb6b71
250344ciclopirox 10 MG/ML Medicated ShampooSCDcb456f2e-6645-4cc4-8e71-299c47ccb6b71
250344ciclopirox 1 % Medicated ShampooSYcb456f2e-6645-4cc4-8e71-299c47ccb6b71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21922-105-52219220105521 BOTTLE in 1 CARTON (21922-105-52) / 120 mL in 1 BOTTLE1 bottle2025-12-03NoNoCurrent