FDA.reportPublic FDA data

Ciclopirox olamine

Product NDC
45802-138
11-digit product format
458020138
Labeler code
45802
Product ID
45802-138_adbf1f16-8243-4280-86b2-fd3dc41af5b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox olamine
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ciclopirox olamine
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-138-11Ciclopirox olamine30 g in 1 TUBECREAM3014
45802-138-11Ciclopirox olamine1 in 1 CARTONCREAM114
45802-138-18Ciclopirox olamine90 g in 1 TUBECREAM9014
45802-138-18Ciclopirox olamine1 in 1 CARTONCREAM114
45802-138-35Ciclopirox olamine1 in 1 CARTONCREAM114
45802-138-35Ciclopirox olamine15 g in 1 TUBECREAM1514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-138-11GM - Gram45802-1389c4db52c-8f4a-446e-aa4b-161dad818ccf12012-07-24
45802-138-18GM - Gram45802-1388fae82be-d4e6-4061-8a1c-8313e948ee9912012-07-24
45802-138-35GM - Gram45802-1387712618a-62dd-4434-bf2f-e091379480c212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CICLOPIROX OLAMINEACTIVE INGREDIENT50MD4SB4APCICLOPIROX OLAMINE CREAM [PERRIGO NEW YORK INC]4
CICLOPIROXACTIVE MOIETY19W019ZDRJCICLOPIROX OLAMINE CREAM [PERRIGO NEW YORK INC]4
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCICLOPIROX OLAMINE CREAM [PERRIGO NEW YORK INC]4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNCICLOPIROX OLAMINE CREAM [PERRIGO NEW YORK INC]4
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATCICLOPIROX OLAMINE CREAM [PERRIGO NEW YORK INC]4
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPCICLOPIROX OLAMINE CREAM [PERRIGO NEW YORK INC]4
MYRISTYL ALCOHOLINACTIVE INGREDIENTV42034O9PUCICLOPIROX OLAMINE CREAM [PERRIGO NEW YORK INC]4
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YCICLOPIROX OLAMINE CREAM [PERRIGO NEW YORK INC]4
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCICLOPIROX OLAMINE CREAM [PERRIGO NEW YORK INC]4
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XCICLOPIROX OLAMINE CREAM [PERRIGO NEW YORK INC]4
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YCICLOPIROX OLAMINE CREAM [PERRIGO NEW YORK INC]4
WATERINACTIVE INGREDIENT059QF0KO0RCICLOPIROX OLAMINE CREAM [PERRIGO NEW YORK INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-138CICLOPIROX OLAMINE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]13Current NDC, Legacy NDC, 6 package rows20250119_1a74ed86-997a-4b86-b54a-b2b2c94e8abb.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
309289ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical CreamPSN74fda3b8-d1f0-4ade-a92a-286f3874f292105
309289ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical CreamPSN6d02fb24-9736-4fe3-b909-1b2172aa2773105
309289ciclopirox 7.7 MG/ML Topical CreamSCD6d02fb24-9736-4fe3-b909-1b2172aa2773105
309289ciclopirox 7.7 MG/ML Topical CreamSCD74fda3b8-d1f0-4ade-a92a-286f3874f292105
309289ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical CreamSY6d02fb24-9736-4fe3-b909-1b2172aa2773105
309289ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical CreamSY74fda3b8-d1f0-4ade-a92a-286f3874f292105
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
309289ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical CreamPSN43a7cab8-7921-43bd-8bfa-a9b96f97c94b100
309289ciclopirox 7.7 MG/ML Topical CreamSCD43a7cab8-7921-43bd-8bfa-a9b96f97c94b100
309289ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical CreamSY43a7cab8-7921-43bd-8bfa-a9b96f97c94b100
309289ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical CreamPSN1a74ed86-997a-4b86-b54a-b2b2c94e8abb14
309289ciclopirox 7.7 MG/ML Topical CreamSCD1a74ed86-997a-4b86-b54a-b2b2c94e8abb14
309289ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical CreamSY1a74ed86-997a-4b86-b54a-b2b2c94e8abb14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-138-11458020138111 TUBE in 1 CARTON (45802-138-11) / 30 g in 1 TUBE1 tube2006-07-190000-00-00NoNoCurrent
45802-138-18458020138181 TUBE in 1 CARTON (45802-138-18) / 90 g in 1 TUBE1 tube2006-12-140000-00-00NoNoCurrent
45802-138-35458020138351 TUBE in 1 CARTON (45802-138-35) / 15 g in 1 TUBE1 tube2006-09-050000-00-00NoNoCurrent