NDC 50458-290

SPORANOX

Itraconazole

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

• Product ID: 50458-290_3a0c4528-7b56-48e7-a683-779d01dffdf2
• NDC: 50458-290
• Product Type: Human Prescription Drug
• Proprietary Name: SPORANOX
• Generic Name: Itraconazole
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1992-09-11
• Marketing Category: NDA / NDA
• Application Number: NDA020083
• Labeler Name: Janssen Pharmaceuticals, Inc.
• Substance Name: ITRACONAZOLE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 50458-290-01

3 BLISTER PACK in 1 CARTON (50458-290-01) > 10 CAPSULE in 1 BLISTER PACK

• Marketing Start Date: 1992-09-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-290-01 [50458029001]

SPORANOX CAPSULE

• Marketing Category: NDA
• Application Number: NDA020083
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1992-09-11

NDC 50458-290-28 [50458029028]

SPORANOX CAPSULE

• Marketing Category: NDA
• Application Number: NDA020083
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1992-09-11

NDC 50458-290-04 [50458029004]

SPORANOX CAPSULE

• Marketing Category: NDA
• Application Number: NDA020083
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1992-09-11

Drug Details

Active Ingredients

Ingredient	Strength
ITRACONAZOLE	100 mg/1

OpenFDA Data

• SPL SET ID: a4d555fa-787c-40fb-bb7d-b0d4f7318fd0
• Manufacturer:
  • Janssen Pharmaceuticals, Inc.
• UNII:
  • 304NUG5GF4
• RxNorm Concept Unique ID - RxCUI:
  • 311204
  • 833164

Pharmacological Class

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

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