NDC 0310-0679

Lynparza

Olaparib

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

• Product ID: 0310-0679_1843c04f-c7f4-44a3-a8be-7b346e015616
• NDC: 0310-0679
• Product Type: Human Prescription Drug
• Proprietary Name: Lynparza
• Generic Name: Olaparib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-08-17
• Marketing Category: NDA / NDA
• Application Number: NDA208558
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: OLAPARIB
• Active Ingredient Strength: 150 mg/1
• Pharm Classes: Poly(ADP-Ribose) Polymerase Inhibitor [EPC],Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0310-0679-12

120 TABLET, FILM COATED in 1 BOTTLE (0310-0679-12)

• Marketing Start Date: 2017-08-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-0679-12 [00310067912]

Lynparza TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA208558
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-08-17

NDC 0310-0679-95 [00310067995]

Lynparza TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA208558
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-08-31

NDC 0310-0679-60 [00310067960]

Lynparza TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA208558
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-08-17

Drug Details

Active Ingredients

Ingredient	Strength
OLAPARIB	150 mg/1

OpenFDA Data

• SPL SET ID: 741ff3e3-dc1a-45a6-84e5-2481b27131aa
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • WOH1JD9AR8
• RxNorm Concept Unique ID - RxCUI:
  • 1942487
  • 1942485
  • 1942482
  • 1942489

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