Ketoconazole

Product NDC
50090-1992
11-digit product format
500901992
Labeler code
50090
Product ID
50090-1992_d132a315-0d44-4a41-b249-5fe5f160484e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketoconazole
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075597
Marketing category
ANDA
Marketing start
1999-12-23
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1992-02023-01-30C16284748780-1f386c64a-22d0-0266-e053-dadaa90a7c1ae63b2fa8-84db-4d42-8659-1905a29bbdb7
50090-1992-12023-01-30C16284748780-1f386c64a-22d0-0266-e053-dadaa90a7c1ae63b2fa8-84db-4d42-8659-1905a29bbdb7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1992-0Ketoconazole30 in 1 BOTTLETABLET305
50090-1992-1Ketoconazole7 in 1 BOTTLETABLET75

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1992KETOCONAZOLE TABLET [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20190328_e63b2fa8-84db-4d42-8659-1905a29bbdb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197853ketoconazole 200 MG Oral TabletPSNe63b2fa8-84db-4d42-8659-1905a29bbdb75
197853ketoconazole 200 MG Oral TabletSCDe63b2fa8-84db-4d42-8659-1905a29bbdb75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1992-05009019920030 in 1 BOTTLEHistorical
50090-1992-1500901992017 TABLET in 1 BOTTLE (50090-1992-1) 7 tablet2015-09-170000-00-00NoNoCurrent