55292-322 : Isturisa 10 mg Oral Tablet, Coated


NDC: 55292-322
Labeler: Recordati Rare Diseases, Inc.
Product Type: Human Prescription Drug
Drug Name:  Isturisa
Dosage Form: Oral Tablet, Coated
Application #: NDA212801
Rev. Date: 


Appearance:


Markings: Y3;NVR
Shapes:  Round
Colors:  Brown
Size (mm): 9
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.

NDC Package Codes:

  • 55292-322-20: 20 TABLET, COATED IN 1 BLISTER PACK (55292‑322‑20)
  • 55292-322-60: 60 TABLET, COATED IN 1 BLISTER PACK (55292‑322‑60)

Active Ingredients:

  • Osilodrostat Phosphate

Dosage Strength:

  • 10 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Croscarmellose Sodium
  • Mannitol
  • Microcrystalline Cellulose
  • Magnesium Stearate
  • Hypromellose, Unspecified
  • Titanium Dioxide
  • Ferric Oxide Red
  • Ferrosoferric Oxide
  • Polyethylene Glycol 4000
  • Talc /

Pharmaceutical Classes:

  • Cortisol Synthesis Inhibitor [EPC]
  • Cytochrome P450 11B1 Inhibitors [MoA]
  • Cytochrome P450 1A2 Inhibitors [MoA]
  • Cytochrome P450 2C19 Inhibitors [MoA]
  • Cytochrome P450 2D6 Inhibitors [MoA]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • Cytochrome P450 3A5 Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 55292-320 Isturisa 1 mg Oral Tablet, Coated by Recordati Rare Diseases, Inc.
  • 55292-321 Isturisa 5 mg Oral Tablet, Coated by Recordati Rare Diseases, Inc.

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 55292-322 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.