sporanox

Generic: itraconazole

Labeler: janssen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sporanox
Generic Name itraconazole
Labeler janssen pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

itraconazole 100 mg/1

Manufacturer
Janssen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50458-290
Product ID 50458-290_b5d1c275-8665-4f63-8232-e34a02c998c7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020083
Marketing Start 1992-09-11
Marketing End 2026-11-30

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Mechanism of Action
cytochrome p450 3a4 inhibitors [moa] p-glycoprotein inhibitors [moa] breast cancer resistance protein inhibitors [moa]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50458290
Hyphenated Format 50458-290

Supplemental Identifiers

RxCUI
311204 833164
UPC
0350458290042
UNII
304NUG5GF4
NUI
N0000175487 M0002083 N0000182141 N0000185503 N0000190113

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sporanox (source: ndc)
Generic Name itraconazole (source: ndc)
Application Number NDA020083 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (50458-290-01) / 10 CAPSULE in 1 BLISTER PACK
  • 30 CAPSULE in 1 BOTTLE (50458-290-04)
source: ndc

Packages (2)

50458-290-01 3 BLISTER PACK in 1 CARTON (50458-290-01) / 10 CAPSULE in 1 BLISTER PACK 50458-290-04 30 CAPSULE in 1 BOTTLE (50458-290-04)

Ingredients (1)

itraconazole (100 mg/1)

Linked Drug Pages (1)

SPORANOX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b5d1c275-8665-4f63-8232-e34a02c998c7", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000185503", "N0000190113"], "upc": ["0350458290042"], "unii": ["304NUG5GF4"], "rxcui": ["311204", "833164"], "spl_set_id": ["a4d555fa-787c-40fb-bb7d-b0d4f7318fd0"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "pharm_class_moa": ["Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]"], "manufacturer_name": ["Janssen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (50458-290-01)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "50458-290-01", "marketing_end_date": "20261130", "marketing_start_date": "19920911"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (50458-290-04)", "package_ndc": "50458-290-04", "marketing_end_date": "20261130", "marketing_start_date": "19920911"}], "brand_name": "SPORANOX", "product_id": "50458-290_b5d1c275-8665-4f63-8232-e34a02c998c7", "dosage_form": "CAPSULE", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "50458-290", "generic_name": "ITRACONAZOLE", "labeler_name": "Janssen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SPORANOX", "active_ingredients": [{"name": "ITRACONAZOLE", "strength": "100 mg/1"}], "application_number": "NDA020083", "marketing_category": "NDA", "marketing_end_date": "20261130", "marketing_start_date": "19920911"}