ketoconazole

Product NDC
50090-0720
11-digit product format
500900720
Labeler code
50090
Product ID
50090-0720_195ca08e-89ec-4980-8156-53903ddcaeae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketoconazole
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA076294
Marketing category
ANDA
Marketing start
2004-04-28
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0720-02023-02-07C16284748780-1f386c649-d325-0266-e053-dadaa90a7c1acafecac3-20d7-4f9d-8be8-521db8bfb6f1
50090-0720-02023-01-30C16284748780-1f386c649-d325-0266-e053-dadaa90a7c1acafecac3-20d7-4f9d-8be8-521db8bfb6f1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0720-0GM - Gram50090-0720e9207f5f-15cb-4106-97cb-17b54399419612021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0720KETOCONAZOLE CREAM [A-S MEDICATION SOLUTIONS]10Legacy NDC20230208_cafecac3-20d7-4f9d-8be8-521db8bfb6f1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0720-0500900720001 TUBE in 1 CARTON (50090-0720-0) > 30 g in 1 TUBE1 tube2014-11-280000-00-00NoNoCurrent