lynparza

Generic: olaparib

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lynparza
Generic Name olaparib
Labeler astrazeneca pharmaceuticals lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

olaparib 100 mg/1

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-0668
Product ID 0310-0668_0142c57f-6211-4638-8c48-c215686871b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208558
Listing Expiration 2026-12-31
Marketing Start 2017-08-17

Pharmacologic Class

Established (EPC)
poly(adp-ribose) polymerase inhibitor [epc]
Mechanism of Action
poly(adp-ribose) polymerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03100668
Hyphenated Format 0310-0668

Supplemental Identifiers

RxCUI
1942482 1942485 1942487 1942489
UNII
WOH1JD9AR8
NUI
N0000191623 N0000191622

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lynparza (source: ndc)
Generic Name olaparib (source: ndc)
Application Number NDA208558 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (0310-0668-12)
  • 60 TABLET, FILM COATED in 1 BOTTLE (0310-0668-60)
  • 60 TABLET, FILM COATED in 1 BOTTLE (0310-0668-95)
source: ndc

Packages (3)

0310-0668-12 120 TABLET, FILM COATED in 1 BOTTLE (0310-0668-12) 0310-0668-60 60 TABLET, FILM COATED in 1 BOTTLE (0310-0668-60) 0310-0668-95 60 TABLET, FILM COATED in 1 BOTTLE (0310-0668-95)

Ingredients (1)

olaparib (100 mg/1)

Linked Drug Pages (1)

Lynparza ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0142c57f-6211-4638-8c48-c215686871b8", "openfda": {"nui": ["N0000191623", "N0000191622"], "unii": ["WOH1JD9AR8"], "rxcui": ["1942482", "1942485", "1942487", "1942489"], "spl_set_id": ["741ff3e3-dc1a-45a6-84e5-2481b27131aa"], "pharm_class_epc": ["Poly(ADP-Ribose) Polymerase Inhibitor [EPC]"], "pharm_class_moa": ["Poly(ADP-Ribose) Polymerase Inhibitors [MoA]"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (0310-0668-12)", "package_ndc": "0310-0668-12", "marketing_start_date": "20170817"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (0310-0668-60)", "package_ndc": "0310-0668-60", "marketing_start_date": "20170817"}, {"sample": true, "description": "60 TABLET, FILM COATED in 1 BOTTLE (0310-0668-95)", "package_ndc": "0310-0668-95", "marketing_start_date": "20220901"}], "brand_name": "Lynparza", "product_id": "0310-0668_0142c57f-6211-4638-8c48-c215686871b8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Poly(ADP-Ribose) Polymerase Inhibitor [EPC]", "Poly(ADP-Ribose) Polymerase Inhibitors [MoA]"], "product_ndc": "0310-0668", "generic_name": "olaparib", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lynparza", "active_ingredients": [{"name": "OLAPARIB", "strength": "100 mg/1"}], "application_number": "NDA208558", "marketing_category": "NDA", "marketing_start_date": "20170817", "listing_expiration_date": "20261231"}