SPORANOX - 50458-290-01 - (ITRACONAZOLE)

Alphabetical Index


Drug Information of SPORANOX

Product NDC: 50458-290
Proprietary Name: SPORANOX
Non Proprietary Name: ITRACONAZOLE
Active Ingredient(s): 100    mg/1 & nbsp;   ITRACONAZOLE
Administration Route(s): ORAL
Dosage Form(s): CAPSULE
Coding System: National Drug Codes(NDC)

Labeler Information of SPORANOX

Product NDC: 50458-290
Labeler Name: Janssen Pharmaceuticals, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA020083
Marketing Category: NDA
Start Marketing Date: 19920911

Package Information of SPORANOX

Package NDC: 50458-290-01
Package Description: 3 BLISTER PACK in 1 CARTON (50458-290-01) > 10 CAPSULE in 1 BLISTER PACK

NDC Information of SPORANOX

NDC Code 50458-290-01
Proprietary Name SPORANOX
Package Description 3 BLISTER PACK in 1 CARTON (50458-290-01) > 10 CAPSULE in 1 BLISTER PACK
Product NDC 50458-290
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name ITRACONAZOLE
Dosage Form Name CAPSULE
Route Name ORAL
Start Marketing Date 19920911
Marketing Category Name NDA
Labeler Name Janssen Pharmaceuticals, Inc.
Substance Name ITRACONAZOLE
Strength Number 100
Strength Unit mg/1
Pharmaceutical Classes Azole Antifungal [EPC],Azoles [Chemical/Ingredient]

Complete Information of SPORANOX


General Information