NDC 0310-0657

Lynparza

Olaparib

Lynparza is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Olaparib.

• Product ID: 0310-0657_040f3b35-6a29-42be-b650-d078ead69d92
• NDC: 0310-0657
• Product Type: Human Prescription Drug
• Proprietary Name: Lynparza
• Generic Name: Olaparib
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2014-12-24
• Marketing End Date: 2020-03-31
• Marketing Category: NDA / NDA
• Application Number: NDA206162
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: OLAPARIB
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Poly(ADP-Ribose) Polymerase Inhibitor [EPC],Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
• NDC Exclude Flag: N

Packaging

NDC 0310-0657-58

112 CAPSULE in 1 BOTTLE (0310-0657-58)

• Marketing Start Date: 2014-12-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-0657-58 [00310065758]

Lynparza CAPSULE

• Marketing Category: NDA
• Application Number: NDA206162
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-12-24
• Marketing End Date: 2020-03-31

Drug Details

Active Ingredients

Ingredient	Strength
OLAPARIB	50 mg/1

OpenFDA Data

• SPL SET ID: 5e31a6a9-864f-4aba-8085-37ee1ddcd499
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • WOH1JD9AR8
• RxNorm Concept Unique ID - RxCUI:
  • 1597593
  • 1597587

Pharmacological Class

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

NDC Crossover Matching brand name "Lynparza" or generic name "Olaparib"

NDC	Brand Name	Generic Name
0310-0657	Lynparza	olaparib
0310-0668	Lynparza	olaparib
0310-0679	Lynparza	olaparib