Ketoconazole

Product NDC
45802-465
11-digit product format
458020465
Labeler code
45802
Product ID
45802-465_85a7e4b1-78a5-41e9-996c-026c58e487c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoconazole
Dosage form
SHAMPOO, SUSPENSION
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA076419
Marketing category
ANDA
Marketing start
2010-01-19
Substance
KETOCONAZOLE
Active strength
20 mg/mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein 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
Ketoconazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOCONAZOLE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR9400W927I
Rxcui106336

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-465-64Ketoconazole120 mL in 1 BOTTLESHAMPOO, SUSPENSION12014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-465-64ML - Milliliter45802-46575e5c0fb-5936-4154-bb25-d2ee20a5376e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOCONAZOLEACTIVE INGREDIENTR9400W927IKETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]6
KETOCONAZOLEACTIVE MOIETYR9400W927IKETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]6
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972DKETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]6
DISODIUM LAURETH SULFOSUCCINATEINACTIVE INGREDIENTD6DH1DTN7EKETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAKETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]6
IMIDUREAINACTIVE INGREDIENTM629807ATLKETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]6
PEG-120 METHYL GLUCOSE DIOLEATEINACTIVE INGREDIENTYM0K64F20VKETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IKETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]6
SODIUM LAURETH-3 SULFATEINACTIVE INGREDIENTBPV390UAP0KETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]6
WATERINACTIVE INGREDIENT059QF0KO0RKETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]6
KETOCONAZOLEACTIVE INGREDIENTR9400W927IKETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
KETOCONAZOLEACTIVE MOIETYR9400W927IKETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972DKETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
DISODIUM LAURETH SULFOSUCCINATEINACTIVE INGREDIENTD6DH1DTN7EKETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAKETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
IMIDUREAINACTIVE INGREDIENTM629807ATLKETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
PEG-120 METHYL GLUCOSE DIOLEATEINACTIVE INGREDIENTYM0K64F20VKETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IKETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
SODIUM LAURETH-3 SULFATEINACTIVE INGREDIENTBPV390UAP0KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RKETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
KETOCONAZOLEACTIVE INGREDIENTR9400W927IKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
KETOCONAZOLEACTIVE INGREDIENTR9400W927IKETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
KETOCONAZOLEACTIVE MOIETYR9400W927IKETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
KETOCONAZOLEACTIVE MOIETYR9400W927IKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972DKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972DKETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
DISODIUM LAURETH SULFOSUCCINATEINACTIVE INGREDIENTD6DH1DTN7EKETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
DISODIUM LAURETH SULFOSUCCINATEINACTIVE INGREDIENTD6DH1DTN7EKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAKETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
IMIDUREAINACTIVE INGREDIENTM629807ATLKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
IMIDUREAINACTIVE INGREDIENTM629807ATLKETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
PEG-120 METHYL GLUCOSE DIOLEATEINACTIVE INGREDIENTYM0K64F20VKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
PEG-120 METHYL GLUCOSE DIOLEATEINACTIVE INGREDIENTYM0K64F20VKETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IKETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RKETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-465KETOCONAZOLE SHAMPOO, SUSPENSION [PADAGIS ISRAEL PHARMACEUTICALS LTD]14Current NDC, Legacy NDC, 1 package rows20250129_99da5233-2760-46f6-8fb3-d9df5da70bfb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106336ketoconazole 2 % Medicated ShampooPSNb200ef76-5ea1-4253-bea5-1e8db0294510107
106336ketoconazole 20 MG/ML Medicated ShampooSCDb200ef76-5ea1-4253-bea5-1e8db0294510107
106336ketoconazole 2 % Medicated ShampooSYb200ef76-5ea1-4253-bea5-1e8db0294510107
106336ketoconazole 2 % Medicated ShampooPSN6d394f8c-d49e-45ff-b7a9-a14aba9bb9cf100
106336ketoconazole 20 MG/ML Medicated ShampooSCD6d394f8c-d49e-45ff-b7a9-a14aba9bb9cf100
106336ketoconazole 2 % Medicated ShampooSY6d394f8c-d49e-45ff-b7a9-a14aba9bb9cf100
106336ketoconazole 2 % Medicated ShampooPSN99da5233-2760-46f6-8fb3-d9df5da70bfb14
106336ketoconazole 20 MG/ML Medicated ShampooSCD99da5233-2760-46f6-8fb3-d9df5da70bfb14
106336ketoconazole 2 % Medicated ShampooSY99da5233-2760-46f6-8fb3-d9df5da70bfb14
106336ketoconazole 2 % Medicated ShampooPSN098afc02-ac71-4214-9fe1-8b519b173bdf11
106336ketoconazole 20 MG/ML Medicated ShampooSCD098afc02-ac71-4214-9fe1-8b519b173bdf11
106336ketoconazole 2 % Medicated ShampooSY098afc02-ac71-4214-9fe1-8b519b173bdf11
106336ketoconazole 2 % Medicated ShampooPSN2c5e02ba-c165-4ffb-bd05-fbd4243725b710
106336ketoconazole 20 MG/ML Medicated ShampooSCD2c5e02ba-c165-4ffb-bd05-fbd4243725b710
106336ketoconazole 2 % Medicated ShampooSY2c5e02ba-c165-4ffb-bd05-fbd4243725b710
106336ketoconazole 2 % Medicated ShampooPSN4578c84a-d438-6740-e063-6294a90a01511
106336ketoconazole 2 % Medicated ShampooPSNb59504cb-dfdd-4c5c-9686-1af6d97306c81
106336ketoconazole 2 % Medicated ShampooPSNd0fcab34-5451-456a-a75a-b1365d5dbc2c1
106336ketoconazole 2 % Medicated ShampooPSNdfac6776-1151-4d01-a099-9de11c9dc7fa1
106336ketoconazole 20 MG/ML Medicated ShampooSCD4578c84a-d438-6740-e063-6294a90a01511
106336ketoconazole 20 MG/ML Medicated ShampooSCDb59504cb-dfdd-4c5c-9686-1af6d97306c81
106336ketoconazole 20 MG/ML Medicated ShampooSCDd0fcab34-5451-456a-a75a-b1365d5dbc2c1
106336ketoconazole 20 MG/ML Medicated ShampooSCDdfac6776-1151-4d01-a099-9de11c9dc7fa1
106336ketoconazole 2 % Medicated ShampooSY4578c84a-d438-6740-e063-6294a90a01511
106336ketoconazole 2 % Medicated ShampooSYb59504cb-dfdd-4c5c-9686-1af6d97306c81
106336ketoconazole 2 % Medicated ShampooSYd0fcab34-5451-456a-a75a-b1365d5dbc2c1
106336ketoconazole 2 % Medicated ShampooSYdfac6776-1151-4d01-a099-9de11c9dc7fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-465-6445802046564120 mL in 1 BOTTLE (45802-465-64) 120 ml2010-01-190000-00-00NoNoCurrent