50419-171 : Stivarga 40 mg Oral Tablet

Labeler: Bayer Healthcare Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Stivarga
Dosage Form: Oral Tablet, Film Coated
Application #: NDA203085
Rev. Date: 


Markings: BAYER
Shapes:  Oval
Colors:  Pink
Size (mm): 16
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:

  • 50419-171-00: 210 TABLET, FILM COATED IN 1 BOX (50419‑171‑00)
  • 50419-171-03: 3 BOTTLE, PLASTIC IN 1 BOX (50419‑171‑03) > 28 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (50419‑171‑01)
  • 50419-171-04: 1 BOTTLE, PLASTIC IN 1 CARTON (50419‑171‑04) > 28 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC
  • 50419-171-06: 4 BOTTLE, PLASTIC IN 1 CARTON (50419‑171‑06) > 21 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (50419‑171‑05)

Active Ingredients:

  • Regorafenib Monohydrate

Dosage Strength:

  • 40 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Croscarmellose Sodium
  • Magnesium Stearate
  • Silicon Dioxide
  • Ferric Oxide Red
  • Ferric Oxide Yellow
  • Lecithin, Soybean
  • Polyethylene Glycol 3350
  • Polyvinyl Alcohol
  • Talc
  • Titanium Dioxide
  • Povidones

Pharmaceutical Classes:

  • Kinase Inhibitor [EPC]
  • Protein Kinase Inhibitors [MoA]
  • Cytochrome P450 2C9 Inhibitors [MoA]


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