NDC 50458-295

SPORANOX

Itraconazole

SPORANOX is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Itraconazole.

• Product ID: 50458-295_66b822be-57bd-4dc3-a8fe-bbafc1f73d3c
• NDC: 50458-295
• Product Type: Human Prescription Drug
• Proprietary Name: SPORANOX
• Generic Name: Itraconazole
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 1997-02-21
• Marketing Category: NDA / NDA
• Application Number: NDA020657
• Labeler Name: Janssen Pharmaceuticals, Inc.
• Substance Name: ITRACONAZOLE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50458-295-15

150 mL in 1 BOTTLE (50458-295-15)

• Marketing Start Date: 1997-02-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-295-15 [50458029515]

SPORANOX SOLUTION

• Marketing Category: NDA
• Application Number: NDA020657
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1997-02-21

Drug Details

Active Ingredients

Ingredient	Strength
ITRACONAZOLE	10 mg/mL

OpenFDA Data

• SPL SET ID: ae50721d-ee15-4ee7-9fe7-afd98c56461b
• Manufacturer:
  • Janssen Pharmaceuticals, Inc.
• UNII:
  • 304NUG5GF4
• RxNorm Concept Unique ID - RxCUI:
  • 348506
  • 152854

Pharmacological Class

• Azole Antifungal [EPC]
• Azoles [CS]
• Cytochrome P450 3A4 Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]
• Breast Cancer Resistance Protein Inhibitors [MoA]

Medicade Reported Pricing

50458029515 SPORANOX 10 MG/ML SOLUTION

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "SPORANOX" or generic name "Itraconazole"

NDC	Brand Name	Generic Name
50458-290	SPORANOX	ITRACONAZOLE
50458-295	SPORANOX	itraconazole
0378-5100	Itraconazole	itraconazole
10147-0150	itraconazole	itraconazole
10147-1700	itraconazole	ITRACONAZOLE
13668-463	Itraconazole	Itraconazole
16714-743	Itraconazole	Itraconazole
16729-271	Itraconazole	ITRACONAZOLE
31722-006	Itraconazole	Itraconazole
42543-113	Itraconazole	Itraconazole
46708-204	ITRACONAZOLE	itraconazole
49884-239	Itraconazole	Itraconazole
50268-450	Itraconazole	Itraconazole
0259-1420	Onmel	ITRACONAZOLE
51862-462	Tolsura	Itraconazole