FDA.reportPublic FDA data

Ketoconazole

Product NDC
51672-4026
11-digit product format
516724026
Labeler code
51672
Product ID
51672-4026_3dd44662-95fb-0d34-e063-6294a90a5fbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoconazole
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
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
51672-4026-0Ketoconazole10 in 1 BLISTER PACKTABLET1012
51672-4026-0Ketoconazole10 in 1 BOXTABLET1012
51672-4026-1Ketoconazole100 in 1 BOTTLETABLET10012
51672-4026-2Ketoconazole500 in 1 BOTTLETABLET50012
51672-4026-6Ketoconazole30 in 1 BOTTLETABLET3012
51672-4026-8Ketoconazole3 in 1 BOXTABLET312
51672-4026-8Ketoconazole10 in 1 BLISTER PACKTABLET1012
51672-4026-9Ketoconazole10 in 1 BLISTER PACKTABLET1012
51672-4026-9Ketoconazole5 in 1 BOXTABLET512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4026-1EA - Each51672-4026a53b7fa1-98a3-49e6-9f13-07af603854d612012-07-24
51672-4026-6EA - Each51672-402612e5aaf9-13ce-432d-9378-bfee61a1e11f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KetoconazoleACTIVE INGREDIENTR9400W927IKETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]5
KetoconazoleACTIVE MOIETYR9400W927IKETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]5
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UKETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]5
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XKETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]5
magnesium stearateINACTIVE INGREDIENT70097M6I30KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]5
povidonesINACTIVE INGREDIENTFZ989GH94EKETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]5
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]5
starch, cornINACTIVE INGREDIENTO8232NY3SJKETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]5
KetoconazoleACTIVE INGREDIENTR9400W927IKETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]4
KetoconazoleACTIVE MOIETYR9400W927IKETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]4
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]4
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XKETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]4
magnesium stearateINACTIVE INGREDIENT70097M6I30KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]4
povidoneINACTIVE INGREDIENTFZ989GH94EKETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJKETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]4
KETOCONAZOLEACTIVE INGREDIENTR9400W927IKETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
KETOCONAZOLEACTIVE INGREDIENTR9400W927IKETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]1
KetoconazoleACTIVE INGREDIENTR9400W927IKETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]1
KETOCONAZOLEACTIVE MOIETYR9400W927IKETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]1
KetoconazoleACTIVE MOIETYR9400W927IKETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]1
KETOCONAZOLEACTIVE MOIETYR9400W927IKETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XKETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XKETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XKETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EKETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]1
povidoneINACTIVE INGREDIENTFZ989GH94EKETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EKETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4KETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJKETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJKETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJKETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4026KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]11Current NDC, Legacy NDC, 9 package rows20240524_8ca815a8-bccb-4ee2-a042-922373329cae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197853ketoconazole 200 MG Oral TabletPSNa9fc4618-4d87-47ef-ab3c-c9ffac3ba9b713
197853ketoconazole 200 MG Oral TabletSCDa9fc4618-4d87-47ef-ab3c-c9ffac3ba9b713
197853ketoconazole 200 MG Oral TabletPSN8ca815a8-bccb-4ee2-a042-922373329cae12
197853ketoconazole 200 MG Oral TabletSCD8ca815a8-bccb-4ee2-a042-922373329cae12
197853ketoconazole 200 MG Oral TabletPSN4baebcab-a237-42c0-9183-6f447a44e37111
197853ketoconazole 200 MG Oral TabletSCD4baebcab-a237-42c0-9183-6f447a44e37111
197853ketoconazole 200 MG Oral TabletPSNf5dc1e67-639f-5476-e053-2995a90a42102
197853ketoconazole 200 MG Oral TabletSCDf5dc1e67-639f-5476-e053-2995a90a42102
197853ketoconazole 200 MG Oral TabletPSN092f1cea-edf2-4536-b378-34b28e281b831
197853ketoconazole 200 MG Oral TabletPSNe96fcf16-543e-4a02-9dac-afad20f791081
197853ketoconazole 200 MG Oral TabletPSNec308fcf-ec39-43af-97e3-98aa8ab997f41
197853ketoconazole 200 MG Oral TabletPSNefbb79b0-5f43-7ada-e053-2995a90ae4701
197853ketoconazole 200 MG Oral TabletSCD092f1cea-edf2-4536-b378-34b28e281b831
197853ketoconazole 200 MG Oral TabletSCDe96fcf16-543e-4a02-9dac-afad20f791081
197853ketoconazole 200 MG Oral TabletSCDec308fcf-ec39-43af-97e3-98aa8ab997f41
197853ketoconazole 200 MG Oral TabletSCDefbb79b0-5f43-7ada-e053-2995a90ae4701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4026-05167240260010 BLISTER PACK in 1 BOX (51672-4026-0) / 10 TABLET in 1 BLISTER PACK10 blister pack1999-06-150000-00-00NoNoCurrent
51672-4026-151672402601100 TABLET in 1 BOTTLE (51672-4026-1) 100 tablet1999-06-150000-00-00NoNoCurrent
51672-4026-251672402602500 TABLET in 1 BOTTLE (51672-4026-2) 500 tablet1999-06-150000-00-00NoNoCurrent
51672-4026-65167240260630 TABLET in 1 BOTTLE (51672-4026-6) 30 tablet1999-06-152026-08-31NoNoCurrent
51672-4026-8516724026083 BLISTER PACK in 1 BOX (51672-4026-8) / 10 TABLET in 1 BLISTER PACK3 blister pack1999-06-150000-00-00NoNoCurrent
51672-4026-9516724026095 BLISTER PACK in 1 BOX (51672-4026-9) / 10 TABLET in 1 BLISTER PACK5 blister pack1999-06-150000-00-00NoNoCurrent