Ciclopirox Olamine

Product NDC
72162-1397
11-digit product format
721621397
Labeler code
72162
Product ID
72162-1397_218842ab-7106-4a3a-900b-3849fa310af1
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
72162-1397-2Ciclopirox Olamine15 g in 1 TUBECREAM15104
72162-1397-2Ciclopirox Olamine1 in 1 CARTONCREAM1104
72162-1397-3Ciclopirox Olamine30 g in 1 TUBECREAM30104
72162-1397-3Ciclopirox Olamine1 in 1 CARTONCREAM1104
72162-1397-9Ciclopirox Olamine1 in 1 CARTONCREAM1104
72162-1397-9Ciclopirox Olamine90 g in 1 TUBECREAM90104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1397-2GM - Gram72162-139772629be3-6189-4674-9186-ba77dccc549912025-02-10
72162-1397-3GM - Gram72162-13975513f505-1606-4228-b571-53a32540fc2e12024-05-16
72162-1397-9GM - Gram72162-1397f8a1af5f-440d-4222-b345-507e13b63a7412024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1397CICLOPIROX OLAMINE CREAM [BRYANT RANCH PREPACK]103Current NDC, 6 package rows20250130_81e31568-6d87-4d0b-ba52-d2794a7cb023.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309289ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical CreamPSN81e31568-6d87-4d0b-ba52-d2794a7cb023104
309289ciclopirox 7.7 MG/ML Topical CreamSCD81e31568-6d87-4d0b-ba52-d2794a7cb023104
309289ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical CreamSY81e31568-6d87-4d0b-ba52-d2794a7cb023104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1397-2721621397021 TUBE in 1 CARTON (72162-1397-2) / 15 g in 1 TUBE1 tube2024-02-08NoNoHistorical
72162-1397-3721621397031 TUBE in 1 CARTON (72162-1397-3) / 30 g in 1 TUBE1 tube2024-02-08NoNoHistorical
72162-1397-9721621397091 TUBE in 1 CARTON (72162-1397-9) / 90 g in 1 TUBE1 tube2024-02-08NoNoHistorical