FDA.reportPublic FDA data

Ketoconazole

Product NDC
33261-739
11-digit product format
332610739
Labeler code
33261
Product ID
33261-739_dcbd7cb5-fde6-4c95-b453-0b5c1c8dd069
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoconazole
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA075319
Marketing category
ANDA
Marketing start
1999-06-15
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
2019-12-31
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
33261-739-302020-01-31C16284748780-19d75b9d1-24ab-f424-e053-dadaa90a57ceKetoconazole Tablets USP, 200 MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-739-30Ketoconazole30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-739-30EA - Each33261-73952585440-0363-4962-abdf-e1b7c60e5bb612015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOCONAZOLEACTIVE INGREDIENTR9400W927IKETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
KETOCONAZOLEACTIVE MOIETYR9400W927IKETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XKETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EKETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJKETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-739KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140110_092f1cea-edf2-4536-b378-34b28e281b83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197853ketoconazole 200 MG Oral TabletPSN092f1cea-edf2-4536-b378-34b28e281b831
197853ketoconazole 200 MG Oral TabletSCD092f1cea-edf2-4536-b378-34b28e281b831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-739-303326107393030 in 1 BOTTLE, PLASTICHistorical