FDA.reportPublic FDA data

KETOCONAZOLE

Product NDC
64380-827
11-digit product format
643800827
Labeler code
64380
Product ID
64380-827_9781ff7c-39a7-4c61-a6ec-7f1947685c6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOCONAZOLE
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA210457
Marketing category
ANDA
Marketing start
2018-06-26
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
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
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
64380-827-06KETOCONAZOLE100 in 1 BOTTLETABLET1008
64380-827-07KETOCONAZOLE500 in 1 BOTTLETABLET5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-827-06EA - Each64380-827fd978ca5-810f-4661-9b83-ad9dbddbc0f112018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-827KETOCONAZOLE TABLET [STRIDES PHARMA SCIENCE LIMITED]7Current NDC, Legacy NDC, 2 package rows20230713_6d4be760-c723-4f54-a854-12c61cf91703.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197853ketoconazole 200 MG Oral TabletPSNf162e616-21b4-49b1-b437-15e21001a6f010
197853ketoconazole 200 MG Oral TabletSCDf162e616-21b4-49b1-b437-15e21001a6f010
197853ketoconazole 200 MG Oral TabletPSN6d4be760-c723-4f54-a854-12c61cf917038
197853ketoconazole 200 MG Oral TabletSCD6d4be760-c723-4f54-a854-12c61cf917038
197853ketoconazole 200 MG Oral TabletPSNaae6c08a-8610-b833-e053-2a95a90a3e6b3
197853ketoconazole 200 MG Oral TabletSCDaae6c08a-8610-b833-e053-2a95a90a3e6b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-827-0664380082706100 TABLET in 1 BOTTLE (64380-827-06) 100 tablet2018-06-260000-00-00NoNoCurrent
64380-827-0764380082707500 TABLET in 1 BOTTLE (64380-827-07) 500 tablet2018-06-260000-00-00NoNoCurrent