FDA.reportPublic FDA data

Ketoconazole

Product NDC
87063-066
11-digit product format
870630066
Labeler code
87063
Product ID
87063-066_491acb10-adec-3d11-e063-6294a90a8e32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoconazole Cream, 2%
Dosage form
CREAM
Route
TOPICAL
Labeler
ASCLEMED USA INC.
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
87063-066-15Ketoconazole15 g in 1 TUBECREAM151
87063-066-15Ketoconazole1 in 1 CARTONCREAM11
87063-066-30Ketoconazole1 in 1 CARTONCREAM11
87063-066-30Ketoconazole30 g in 1 TUBECREAM301
87063-066-60Ketoconazole1 in 1 CARTONCREAM11
87063-066-60Ketoconazole60 g in 1 TUBECREAM601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
203088ketoconazole 2 % Topical CreamPSN6f1a5365-99df-4169-9382-14c2643e561d1
203088ketoconazole 20 MG/ML Topical CreamSCD6f1a5365-99df-4169-9382-14c2643e561d1
203088ketoconazole 2 % Topical CreamSY6f1a5365-99df-4169-9382-14c2643e561d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87063-066-15870630066151 TUBE in 1 CARTON (87063-066-15) / 15 g in 1 TUBE1 tube2026-01-20NoNoHistorical
87063-066-30870630066301 TUBE in 1 CARTON (87063-066-30) / 30 g in 1 TUBE1 tube2026-01-20NoNoHistorical
87063-066-60870630066601 TUBE in 1 CARTON (87063-066-60) / 60 g in 1 TUBE1 tube2026-01-20NoNoHistorical