NDC 69660-201

Rubraca

Rucaparib

Rubraca is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Clovis Oncology, Inc.. The primary component is Rucaparib Camsylate.

• Product ID: 69660-201_0b0db8b3-379e-4a8b-b425-11b3387ca405
• NDC: 69660-201
• Product Type: Human Prescription Drug
• Proprietary Name: Rubraca
• Generic Name: Rucaparib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-12-19
• Marketing Category: NDA / NDA
• Application Number: NDA209115
• Labeler Name: Clovis Oncology, Inc.
• Substance Name: RUCAPARIB CAMSYLATE
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 69660-201-91

60 TABLET, FILM COATED in 1 BOTTLE (69660-201-91)

• Marketing Start Date: 2016-12-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69660-201-91 [69660020191]

Rubraca TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209115
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-12-19

Drug Details

Active Ingredients

Ingredient	Strength
RUCAPARIB CAMSYLATE	200 mg/1

OpenFDA Data

• SPL SET ID: a6d46c03-bb1d-417b-b8e5-3bffe352fe29
• Manufacturer:
  • Clovis Oncology, Inc.
• UNII:
  • 41AX9SJ8KO
• RxNorm Concept Unique ID - RxCUI:
  • 1921587
  • 1862595
  • 1862584
  • 1862590
  • 1921589
  • 1862593
• UPC Code:
  • 0369660202910
  • 0369660201913
  • 0369660203917

Pharmacological Class

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

NDC Crossover Matching brand name "Rubraca" or generic name "Rucaparib"

NDC	Brand Name	Generic Name
69660-201	Rubraca	rucaparib
69660-202	Rubraca	rucaparib
69660-203	Rubraca	rucaparib