FDA.reportPublic FDA data

Ciclopirox Olamine

Product NDC
45802-400
11-digit product format
458020400
Labeler code
45802
Product ID
45802-400_ae67550c-f609-40a6-8f0c-8909d360de0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox Olamine
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
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
45802-400-46Ciclopirox Olamine1 in 1 CARTONSUSPENSION19
45802-400-46Ciclopirox Olamine60 mL in 1 BOTTLESUSPENSION609
45802-400-49Ciclopirox Olamine30 mL in 1 BOTTLESUSPENSION309
45802-400-49Ciclopirox Olamine1 in 1 CARTONSUSPENSION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-400-46ML - Milliliter45802-400fcd30868-d8e6-4d9f-a1e5-9f27cdcf24fa12012-07-24
45802-400-49ML - Milliliter45802-4002ff0072a-ed91-42a8-a83c-776c8ad6064a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CICLOPIROX OLAMINEACTIVE INGREDIENT50MD4SB4APCICLOPIROX OLAMINE SUSPENSION [PERRIGO NEW YORK INC]2
CICLOPIROXACTIVE MOIETY19W019ZDRJCICLOPIROX OLAMINE SUSPENSION [PERRIGO NEW YORK INC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCICLOPIROX OLAMINE SUSPENSION [PERRIGO NEW YORK INC]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNCICLOPIROX OLAMINE SUSPENSION [PERRIGO NEW YORK INC]2
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATCICLOPIROX OLAMINE SUSPENSION [PERRIGO NEW YORK INC]2
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPCICLOPIROX OLAMINE SUSPENSION [PERRIGO NEW YORK INC]2
MYRISTYL ALCOHOLINACTIVE INGREDIENTV42034O9PUCICLOPIROX OLAMINE SUSPENSION [PERRIGO NEW YORK INC]2
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YCICLOPIROX OLAMINE SUSPENSION [PERRIGO NEW YORK INC]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCICLOPIROX OLAMINE SUSPENSION [PERRIGO NEW YORK INC]2
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XCICLOPIROX OLAMINE SUSPENSION [PERRIGO NEW YORK INC]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YCICLOPIROX OLAMINE SUSPENSION [PERRIGO NEW YORK INC]2
WATERINACTIVE INGREDIENT059QF0KO0RCICLOPIROX OLAMINE SUSPENSION [PERRIGO NEW YORK INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-400CICLOPIROX OLAMINE SUSPENSION [PADAGIS ISRAEL PHARMACEUTICALS LTD]8Current NDC, Legacy NDC, 4 package rows20250125_eadbd29d-5990-4987-833f-40cd0b2d2868.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
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
309290ciclopirox 0.77 % Topical LotionPSN835a6370-f331-4b15-b6fa-beafe027f187100
309290ciclopirox 0.77 % Topical LotionPSN9130e3c7-566b-411b-b54d-c894e9094b5b100
309290ciclopirox 7.7 MG/ML Topical LotionSCD835a6370-f331-4b15-b6fa-beafe027f187100
309290ciclopirox 7.7 MG/ML Topical LotionSCD9130e3c7-566b-411b-b54d-c894e9094b5b100
309290ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical LotionSY835a6370-f331-4b15-b6fa-beafe027f187100
309290ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical LotionSY9130e3c7-566b-411b-b54d-c894e9094b5b100
309290ciclopirox 0.77 % Topical LotionSY835a6370-f331-4b15-b6fa-beafe027f187100
309290ciclopirox 0.77 % Topical LotionSY9130e3c7-566b-411b-b54d-c894e9094b5b100
309290ciclopirox 0.77 % Topical LotionPSNeadbd29d-5990-4987-833f-40cd0b2d28689
309290ciclopirox 7.7 MG/ML Topical LotionSCDeadbd29d-5990-4987-833f-40cd0b2d28689
309290ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical LotionSYeadbd29d-5990-4987-833f-40cd0b2d28689
309290ciclopirox 0.77 % Topical LotionSYeadbd29d-5990-4987-833f-40cd0b2d28689

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-400-46458020400461 BOTTLE in 1 CARTON (45802-400-46) / 60 mL in 1 BOTTLE1 bottle2006-12-290000-00-00NoNoCurrent
45802-400-49458020400491 BOTTLE in 1 CARTON (45802-400-49) / 30 mL in 1 BOTTLE1 bottle2006-12-290000-00-00NoNoCurrent