FDA.reportPublic FDA data

Ketoconazole

Product NDC
50090-6046
11-digit product format
500906046
Labeler code
50090
Product ID
50090-6046_28bd2e80-7d01-4fa6-84f5-2ca84c90ca61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoconazole Cream, 2%
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA212443
Marketing category
ANDA
Marketing start
2021-05-27
Substance
KETOCONAZOLE
Active strength
20 mg/g
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/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR9400W927I
Rxcui203088

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
50090-6046-0Ketoconazole1 in 1 CARTONCREAM15
50090-6046-0Ketoconazole30 g in 1 TUBECREAM305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6046-0GM - Gram50090-604645a1e9d3-d685-41ad-8822-93cf330b238312022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6046KETOCONAZOLE (KETOCONAZOLE CREAM, 2%) CREAM [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20231122_750bcfc3-b0e4-407e-ad12-e81b183f3b00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
203088ketoconazole 2 % Topical CreamPSN750bcfc3-b0e4-407e-ad12-e81b183f3b005
203088ketoconazole 20 MG/ML Topical CreamSCD750bcfc3-b0e4-407e-ad12-e81b183f3b005
203088ketoconazole 2 % Topical CreamSY750bcfc3-b0e4-407e-ad12-e81b183f3b005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6046-0500906046001 TUBE in 1 CARTON (50090-6046-0) / 30 g in 1 TUBE1 tube2022-07-180000-00-00NoNoCurrent