50458-290 : Sporanox Pulsepak

Labeler: Janssen Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Sporanox
Dosage Form: Oral Capsule
Application #: NDA020083
Rev. Date: 


Shapes:  Capsule
Colors:  Pink / Blue
Size (mm): 22
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

JANSSEN SPORANOX 100: (50458-290) Sporanox Pulsepak by Janssen Pharmaceuticals, Inc.
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 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)
  • 50458-290-28: 7 POUCH IN 1 DOSE PACK (50458‑290‑28) > 1 BLISTER PACK IN 1 POUCH > 4 CAPSULE IN 1 BLISTER PACK

Active Ingredients:

  • Itraconazole

Dosage Strength:

  • 100 mg

Inactive Ingredients:

  • Gelatin
  • Hypromelloses
  • Polyethylene Glycols
  • Starch, Corn
  • Sucrose
  • Titanium Dioxide
  • Fd&c Blue No. 1
  • Fd&c Blue No. 2
  • D&c Red No. 22
  • D&c Red No. 28

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 50458-295 Sporanox 10 mg/ml Oral Solution by Janssen Pharmaceuticals, Inc.
  • 63629-1647 Sporanox 100 mg Oral Capsule by Bryant Ranch Prepack


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NDC 50458-290 QR Code

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