FDA.reportPublic FDA data

KETOCONAZOLE

Product NDC
35573-433
11-digit product format
355730433
Labeler code
35573
Product ID
35573-433_748e48d8-09d3-413c-b724-883b6b47f01e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketoconazole
Dosage form
TABLET
Route
ORAL
Labeler
Burel Pharmaceuticals, LLC
Application
ANDA075912
Marketing category
ANDA
Marketing start
2020-04-10
Substance
KETOCONAZOLE
Active strength
200 mg/1
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
KETOCONAZOLE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR9400W927I
Rxcui197853

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
35573-433-02KETOCONAZOLE100 in 1 BOTTLETABLET1005
35573-433-30KETOCONAZOLE30 in 1 BOTTLETABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35573-433-02EA - Each35573-433e99fb1aa-21ae-4b23-b552-c42c959a93c012020-05-08
35573-433-30EA - Each35573-43329b8a030-98fd-4499-bf28-d27f6fc3060512020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35573-433KETOCONAZOLE TABLET [BUREL PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 2 package rows20230805_57e81e13-b395-4dbd-b660-3038de41a838.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197853ketoconazole 200 MG Oral TabletPSN3ea8a22b-cd61-4623-a11f-43e3396b50fa102
197853ketoconazole 200 MG Oral TabletSCD3ea8a22b-cd61-4623-a11f-43e3396b50fa102
197853ketoconazole 200 MG Oral TabletPSN57e81e13-b395-4dbd-b660-3038de41a8385
197853ketoconazole 200 MG Oral TabletSCD57e81e13-b395-4dbd-b660-3038de41a8385
197853ketoconazole 200 MG Oral TabletPSN517c29fc-2a2a-4bd5-a8bb-b464a65d2be03
197853ketoconazole 200 MG Oral TabletSCD517c29fc-2a2a-4bd5-a8bb-b464a65d2be03
197853ketoconazole 200 MG Oral TabletPSNbc189ce2-3f10-260d-e053-2a95a90ae8082
197853ketoconazole 200 MG Oral TabletSCDbc189ce2-3f10-260d-e053-2a95a90ae8082

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35573-433-0235573043302100 TABLET in 1 BOTTLE (35573-433-02) 100 tablet2020-04-100000-00-00NoNoCurrent
35573-433-303557304333030 TABLET in 1 BOTTLE (35573-433-30) 30 tablet2020-04-100000-00-00NoNoCurrent