FDA.reportPublic FDA data

Ciclopirox Olamine

Product NDC
63629-8625
11-digit product format
636298625
Labeler code
63629
Product ID
63629-8625_cdc411f9-07e8-4bd7-ab52-526bee8241e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox Olamine
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA077364
Marketing category
ANDA
Marketing start
2006-07-19
Substance
CICLOPIROX OLAMINE
Active strength
7.7 mg/g
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/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii50MD4SB4AP
Rxcui309289

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
63629-8625-1Ciclopirox Olamine30 g in 1 TUBECREAM30107
63629-8625-1Ciclopirox Olamine1 in 1 CARTONCREAM1107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8625-1GM - Gram63629-862506db4b2e-1e59-4283-9938-d015072f051512023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8625CICLOPIROX OLAMINE CREAM [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 2 package rows20240823_aa326ade-ff55-4355-b6c7-205d6d88d0a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309289ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical CreamPSNaa326ade-ff55-4355-b6c7-205d6d88d0a3107
309289ciclopirox 7.7 MG/ML Topical CreamSCDaa326ade-ff55-4355-b6c7-205d6d88d0a3107
309289ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical CreamSYaa326ade-ff55-4355-b6c7-205d6d88d0a3107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8625-1636298625011 TUBE in 1 CARTON (63629-8625-1) / 30 g in 1 TUBE1 tube2006-07-190000-00-00NoNoCurrent