69656-103 : Zejula 100 mg Oral Capsule


NDC: 69656-103
Labeler: Tesaro, Inc.
Product Type: Human Prescription Drug
Drug Name:  Zejula
Dosage Form: Oral Capsule
Application #: NDA208447
Rev. Date: 


Appearance:


Markings: 100;mg;Niraparib
Shapes:  Capsule
Colors:  White / Purple
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.

NDC Package Codes:

  • 69656-103-30: 30 CAPSULE IN 1 BOTTLE (69656‑103‑30)
  • 69656-103-61: 30 CAPSULE IN 1 BOTTLE (69656‑103‑61)
  • 69656-103-90: 90 CAPSULE IN 1 BOTTLE (69656‑103‑90)

Active Ingredients:

  • Niraparib

Dosage Strength:

  • 100 mg

Inactive Ingredients:

  • Magnesium Stearate
  • Lactose Monohydrate
  • Titanium Dioxide
  • Gelatin Hydrolysate (Porcine Skin, Mw 3000)
  • Fd&c Blue No. 1
  • Erythrosine Sodium Anhydrous
  • Fd&c Yellow No. 5
  • Magnesium Stearate
  • Lactose Monohydrate
  • Titanium Dioxide
  • Gelatin, Unspecified
  • Fd&c Blue No. 1
  • Fd&c Red No. 3
  • Fd&c Yellow No. 5 /

Pharmaceutical Classes:

  • Poly(ADP-Ribose) Polymerase Inhibitor [EPC]
  • Poly(ADP-Ribose) Polymerase Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 0173-0909 Zejula 100 mg Oral Tablet, Film Coated by Glaxosmithkline LLC
  • 0173-0912 Zejula 200 mg Oral Tablet, Film Coated by Glaxosmithkline LLC
  • 0173-0915 Zejula 300 mg Oral Tablet, Film Coated by Glaxosmithkline LLC

NDC QR Code

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

NDC 69656-103 QR Code

< Prev: 69656-102Next: 69658-101 >

Related Discussions:

Zejula (Niraparib) Discussion Forum
This is my 5th week on Zejula 200mg daily. As suggested by the pharmacy nurse I take it at night to help with possible s... 4 replies




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.