NDC 69656-103

ZEJULA

Niraparib

ZEJULA is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Niraparib.

• Product ID: 69656-103_260fc974-c8bc-44c5-8f72-b2424254c10a
• NDC: 69656-103
• Product Type: Human Prescription Drug
• Proprietary Name: ZEJULA
• Generic Name: Niraparib
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2017-03-27
• Marketing Category: NDA / NDA
• Application Number: NDA208447
• Labeler Name: GlaxoSmithKline LLC
• Substance Name: NIRAPARIB
• Active Ingredient Strength: 100 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 69656-103-30

30 CAPSULE in 1 BOTTLE (69656-103-30)

• Marketing Start Date: 2018-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69656-103-30 [69656010330]

ZEJULA CAPSULE

• Marketing Category: NDA
• Application Number: NDA208447
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-01

NDC 69656-103-90 [69656010390]

ZEJULA CAPSULE

• Marketing Category: NDA
• Application Number: NDA208447
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-03-27

Drug Details

Active Ingredients

Ingredient	Strength
NIRAPARIB	100 mg/1

OpenFDA Data

• SPL SET ID: 0fe9d533-67a9-4981-978a-1e84755ae30b
• Manufacturer:
  • TESARO, Inc.
• UNII:
  • HMC2H89N35
• RxNorm Concept Unique ID - RxCUI:
  • 1918242
  • 1918236

Pharmacological Class

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