50458-290 : Sporanox Pulsepak


NDC: 50458-290
Labeler: Janssen Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Sporanox
Dosage Form: Oral Capsule
Application #: NDA020083
Rev. Date: 


Appearance:


Markings: JANSSEN;SPORANOX;100
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]
  • Breast Cancer Resistance Protein Inhibitors [MoA]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • P-Glycoprotein 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

NDC QR Code

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NDC 50458-290 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.