70518-0714 : Prezcobix Oral Tablet, Film Coated

Labeler: Remedyrepack Inc.
Product Type: Human Prescription Drug
Drug Name:  Prezcobix
Dosage Form: Oral Tablet, Film Coated
Application #: NDA205395
Rev. Date: 


Markings: 800;TG
Shapes:  Oval
Colors:  Pink
Size (mm): 23
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:

  • 70518-0714-0: 30 TABLET, FILM COATED IN 1 BLISTER PACK (70518‑0714‑0)

Active Ingredients:

  • Darunavir Ethanolate
  • Cobicistat

Dosage Strength:

  • 800 mg
  • 150 mg

Inactive Ingredients:

  • Hypromellose, Unspecified
  • Microcrystalline Cellulose
  • Silicon Dioxide
  • Crospovidone (15 Mpa.s At 5%)
  • Magnesium Stearate
  • Polyvinyl Alcohol, Unspecified
  • Titanium Dioxide
  • Polyethylene Glycol, Unspecified
  • Talc
  • Ferric Oxide Red
  • Ferrosoferric Oxide

Pharmaceutical Classes:

  • HIV Protease Inhibitors [MoA]
  • Protease Inhibitor [EPC]
  • Cytochrome P450 3A Inhibitors [MoA]
  • Cytochrome P450 2D6 Inhibitors [MoA]
  • Cytochrome P450 3A Inhibitor [EPC]
  • P-Glycoprotein Inhibitors [MoA]
  • Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]
  • Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
  • Breast Cancer Resistance Protein Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 50090-1723 Prezcobix Oral Tablet, Film Coated by A-s Medication Solutions
  • 54569-6594 Prezcobix Oral Tablet, Film Coated by A-s Medication Solutions
  • 59676-575 Prezcobix Oral Tablet, Film Coated by Janssen Products Lp


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