FDA.reportPublic FDA data

Ciclopirox Olamine

Product NDC
72162-1406
11-digit product format
721621406
Labeler code
72162
Product ID
72162-1406_bd13e41b-98e8-41f4-af32-10df498f93cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox Olamine
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA077676
Marketing category
ANDA
Marketing start
2006-12-29
Substance
CICLOPIROX OLAMINE
Active strength
7.7 mg/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 Olamine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CICLOPIROX OLAMINE7.7 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii50MD4SB4AP
Rxcui309290

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1406-3Ciclopirox Olamine30 mL in 1 BOTTLESUSPENSION30103
72162-1406-3Ciclopirox Olamine1 in 1 CARTONSUSPENSION1103
72162-1406-6Ciclopirox Olamine1 in 1 CARTONSUSPENSION1103
72162-1406-6Ciclopirox Olamine60 mL in 1 BOTTLESUSPENSION60103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1406-3ML - Milliliter72162-1406dda894df-005a-43bb-a7ba-e43e31bc5de212023-12-05
72162-1406-6ML - Milliliter72162-140651672362-9493-4104-8e5f-de36da8d880512025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1406CICLOPIROX OLAMINE SUSPENSION [BRYANT RANCH PREPACK]102Current NDC, 4 package rows20241226_399fd2d5-f5a2-4bce-ad4e-ce70060a14b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309290ciclopirox 0.77 % Topical LotionPSN399fd2d5-f5a2-4bce-ad4e-ce70060a14b0103
309290ciclopirox 7.7 MG/ML Topical LotionSCD399fd2d5-f5a2-4bce-ad4e-ce70060a14b0103
309290ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical LotionSY399fd2d5-f5a2-4bce-ad4e-ce70060a14b0103
309290ciclopirox 0.77 % Topical LotionSY399fd2d5-f5a2-4bce-ad4e-ce70060a14b0103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1406-3721621406031 BOTTLE in 1 CARTON (72162-1406-3) / 30 mL in 1 BOTTLE1 bottle2023-10-02NoNoCurrent
72162-1406-6721621406061 BOTTLE in 1 CARTON (72162-1406-6) / 60 mL in 1 BOTTLE1 bottle2023-10-02NoNoCurrent