FDA.reportPublic FDA data

Ketoconazole

Product NDC
71335-0439
11-digit product format
713350439
Labeler code
71335
Product ID
71335-0439_ae8e3f89-1b77-4934-9252-64d9888d13fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoconazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075319
Marketing category
ANDA
Marketing start
1999-06-15
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
71335-0439-1Ketoconazole10 in 1 BOTTLETABLET1011
71335-0439-2Ketoconazole30 in 1 BOTTLETABLET3011
71335-0439-3Ketoconazole40 in 1 BOTTLETABLET4011
71335-0439-4Ketoconazole60 in 1 BOTTLETABLET6011
71335-0439-5Ketoconazole8 in 1 BOTTLETABLET811
71335-0439-6Ketoconazole7 in 1 BOTTLETABLET711
71335-0439-7Ketoconazole14 in 1 BOTTLETABLET1411
71335-0439-8Ketoconazole90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0439-6EA - Each71335-043965e289ce-9a83-4743-9d23-4c217d8ce02612018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0439KETOCONAZOLE TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 8 package rows20240524_4baebcab-a237-42c0-9183-6f447a44e371.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197853ketoconazole 200 MG Oral TabletPSN4baebcab-a237-42c0-9183-6f447a44e37111
197853ketoconazole 200 MG Oral TabletSCD4baebcab-a237-42c0-9183-6f447a44e37111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0439-17133504390110 TABLET in 1 BOTTLE (71335-0439-1) 10 tablet2010-04-280000-00-00NoNoCurrent
71335-0439-27133504390230 TABLET in 1 BOTTLE (71335-0439-2) 30 tablet2010-04-280000-00-00NoNoCurrent
71335-0439-37133504390340 TABLET in 1 BOTTLE (71335-0439-3) 40 tablet2010-04-280000-00-00NoNoCurrent
71335-0439-47133504390460 TABLET in 1 BOTTLE (71335-0439-4) 60 tablet2010-04-280000-00-00NoNoCurrent
71335-0439-5713350439058 TABLET in 1 BOTTLE (71335-0439-5) 8 tablet2010-04-280000-00-00NoNoCurrent
71335-0439-6713350439067 TABLET in 1 BOTTLE (71335-0439-6) 7 tablet2010-04-280000-00-00NoNoCurrent
71335-0439-77133504390714 TABLET in 1 BOTTLE (71335-0439-7) 14 tablet2010-04-280000-00-00NoNoCurrent
71335-0439-87133504390890 TABLET in 1 BOTTLE (71335-0439-8) 90 tablet2010-04-280000-00-00NoNoCurrent