FDA.reportPublic FDA data

Ciclopirox Olamine

Product NDC
63629-2522
11-digit product format
636292522
Labeler code
63629
Product ID
63629-2522_a7508900-9b1a-49bc-ab18-b86cdf1025d9
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
63629-2522-1Ciclopirox Olamine1 in 1 CARTONSUSPENSION1107
63629-2522-1Ciclopirox Olamine30 mL in 1 BOTTLESUSPENSION30107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2522-1ML - Milliliter63629-25220648b7ca-830f-4c4f-872c-5e65162d3ae712021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2522CICLOPIROX OLAMINE SUSPENSION [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 2 package rows20250221_246585a0-e53e-4f54-8f8b-76536011ab23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309290ciclopirox 0.77 % Topical LotionPSN246585a0-e53e-4f54-8f8b-76536011ab23107
309290ciclopirox 7.7 MG/ML Topical LotionSCD246585a0-e53e-4f54-8f8b-76536011ab23107
309290ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical LotionSY246585a0-e53e-4f54-8f8b-76536011ab23107
309290ciclopirox 0.77 % Topical LotionSY246585a0-e53e-4f54-8f8b-76536011ab23107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2522-1636292522011 BOTTLE in 1 CARTON (63629-2522-1) / 30 mL in 1 BOTTLE1 bottle2006-12-290000-00-00NoNoCurrent