FDA.reportPublic FDA data

Nizoral

Product NDC
55505-196
11-digit product format
555050196
Labeler code
55505
Product ID
55505-196_443a0d0c-3098-4c35-97f8-8d01a7b3c83a
Type
HUMAN OTC DRUG
Nonproprietary name
Ketoconazole
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Kramer Laboratories
Application
NDA020310
Marketing category
NDA
Marketing start
2022-06-16
Substance
KETOCONAZOLE
Active strength
10 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOCONAZOLE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR9400W927I
Rxcui240812, 608844

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55505-196-33Nizoral1 in 1 CARTONSHAMPOO17
55505-196-33Nizoral125 mL in 1 BOTTLESHAMPOO1257
55505-196-40Nizoral200 mL in 1 BOTTLESHAMPOO2007
55505-196-40Nizoral1 in 1 CARTONSHAMPOO17
55505-196-47Nizoral4 mL in 1 PACKETSHAMPOO47
55505-196-57Nizoral200 mL in 1 BOTTLESHAMPOO2007
55505-196-57Nizoral2 in 1 CARTONSHAMPOO27
55505-196-64Nizoral325 mL in 1 BOTTLESHAMPOO3257
55505-196-64Nizoral1 in 1 CARTONSHAMPOO17
55505-196-65Nizoral1 in 1 CARTONSHAMPOO17
55505-196-65Nizoral400 mL in 1 CARTONSHAMPOO4007
55505-196-68Nizoral3 in 1 CARTONSHAMPOO37
55505-196-68Nizoral200 mL in 1 BOTTLESHAMPOO2007
55505-196-72Nizoral2 in 1 CARTONSHAMPOO27
55505-196-72Nizoral325 mL in 1 BOTTLESHAMPOO3257
55505-196-84Nizoral400 mL in 1 BOTTLESHAMPOO4007
55505-196-84Nizoral2 in 1 CARTONSHAMPOO27
55505-196-85Nizoral1 in 1 CARTONSHAMPOO17
55505-196-85Nizoral562 mL in 1 BOTTLESHAMPOO5627

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55505-196NIZORAL (KETOCONAZOLE) SHAMPOO [KRAMER LABORATORIES]5Current NDC, Legacy NDC, 19 package rows20250101_a17b7424-ee7e-4fcc-b6b3-0904932ae319.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240812ketoconazole 1 % Medicated ShampooPSNa17b7424-ee7e-4fcc-b6b3-0904932ae3197
608844Nizoral A-D 1 % Medicated ShampooPSNa17b7424-ee7e-4fcc-b6b3-0904932ae3197
608844ketoconazole 10 MG/ML Medicated Shampoo [Nizoral]SBDa17b7424-ee7e-4fcc-b6b3-0904932ae3197
240812ketoconazole 10 MG/ML Medicated ShampooSCDa17b7424-ee7e-4fcc-b6b3-0904932ae3197
240812ketoconazole 1 % Medicated ShampooSYa17b7424-ee7e-4fcc-b6b3-0904932ae3197
608844Nizoral 1 % Medicated ShampooSYa17b7424-ee7e-4fcc-b6b3-0904932ae3197
608844Nizoral 10 MG/ML Medicated ShampooSYa17b7424-ee7e-4fcc-b6b3-0904932ae3197

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55505-196-33555050196331 BOTTLE in 1 CARTON (55505-196-33) / 125 mL in 1 BOTTLE1 bottle2022-06-160000-00-00NoNoCurrent
55505-196-40555050196401 BOTTLE in 1 CARTON (55505-196-40) / 200 mL in 1 BOTTLE1 bottle2022-06-160000-00-00NoNoCurrent
55505-196-47555050196474 mL in 1 PACKET (55505-196-47) 4 ml2024-03-01NoNoHistorical
55505-196-57555050196572 BOTTLE in 1 CARTON (55505-196-57) / 200 mL in 1 BOTTLE2 bottle2023-04-29NoNoHistorical
55505-196-64555050196641 BOTTLE in 1 CARTON (55505-196-64) > 325 mL in 1 BOTTLE1 bottle2022-06-160000-00-00NoNoCurrent
55505-196-65555050196651 CARTON in 1 CARTON (55505-196-65) / 400 mL in 1 CARTON1 carton2022-06-160000-00-00NoNoCurrent
55505-196-68555050196683 BOTTLE in 1 CARTON (55505-196-68) / 200 mL in 1 BOTTLE3 bottle2022-10-15NoNoHistorical
55505-196-72555050196722 BOTTLE in 1 CARTON (55505-196-72) / 325 mL in 1 BOTTLE2 bottle2023-12-01NoNoHistorical
55505-196-84555050196842 BOTTLE in 1 CARTON (55505-196-84) / 400 mL in 1 BOTTLE2 bottle2025-06-01NoNoHistorical
55505-196-85555050196851 BOTTLE in 1 CARTON (55505-196-85) / 562 mL in 1 BOTTLE1 bottle2026-01-12NoNoHistorical