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Ketoconazole - 0378-0261-01 - (ketoconazole)

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Drug Information of Ketoconazole

Product NDC: 0378-0261
Proprietary Name: Ketoconazole
Non Proprietary Name: ketoconazole
Active Ingredient(s): 200    mg/1 & nbsp;   ketoconazole
Administration Route(s): ORAL
Dosage Form(s): TABLET
Coding System: National Drug Codes(NDC)

Labeler Information of Ketoconazole

Product NDC: 0378-0261
Labeler Name: Mylan Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA075597
Marketing Category: ANDA
Start Marketing Date: 20130226

Package Information of Ketoconazole

Package NDC: 0378-0261-01
Package Description: 100 TABLET in 1 BOTTLE, PLASTIC (0378-0261-01)

NDC Information of Ketoconazole

NDC Code 0378-0261-01
Proprietary Name Ketoconazole
Package Description 100 TABLET in 1 BOTTLE, PLASTIC (0378-0261-01)
Product NDC 0378-0261
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name ketoconazole
Dosage Form Name TABLET
Route Name ORAL
Start Marketing Date 20130226
Marketing Category Name ANDA
Labeler Name Mylan Pharmaceuticals Inc.
Substance Name KETOCONAZOLE
Strength Number 200
Strength Unit mg/1
Pharmaceutical Classes Azole Antifungal [EPC],Azoles [Chemical/Ingredient]

Complete Information of Ketoconazole


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