57894-195 : Zytiga 500 mg Oral Tablet, Film Coated


NDC57894-195
Labeler: Janssen Biotech, Inc.
Product Type: Human Prescription Drug
Drug Name:  Zytiga
Dosage Form: Oral Tablet, Film Coated
Application #: NDA202379
Rev. Date: 


Appearance:


Markings: AA;500
Shapes:  Oval
Colors:  Purple
Size (mm): 20
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:

  • 57894-195-06: 60 TABLET, FILM COATED IN 1 BOTTLE (57894‑195‑06)
  • 57894-195-15: 60 TABLET, FILM COATED IN 1 BOTTLE (57894‑195‑15)

Active Ingredients:

  • Abiraterone Acetate

Dosage Strength:

  • 500 mg

Inactive Ingredients:

  • Microcrystalline Cellulose
  • Croscarmellose Sodium
  • Hypromellose 2910 (15 Mpa.s)
  • Lactose Monohydrate
  • Magnesium Stearate
  • Silicon Dioxide
  • Sodium Lauryl Sulfate
  • Polyvinyl Alcohol, Unspecified
  • Titanium Dioxide
  • Polyethylene Glycol 3350
  • Talc
  • Ferric Oxide Red
  • Ferrosoferric Oxide
  • Water

Pharmaceutical Classes:

  • Cytochrome P450 17A1 Inhibitors [MoA]
  • Cytochrome P450 17A1 Inhibitor [EPC]
  • Cytochrome P450 2D6 Inhibitors [MoA]
  • Cytochrome P450 2C8 Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 57894-150 Zytiga 250 mg Oral Tablet by Janssen Biotech, Inc.
  • 57894-184 Zytiga 250 mg Oral Tablet, Film Coated by Janssen Biotech, Inc.

NDC QR Code

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

NDC 57894-195 QR Code

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