Drug Information

Product NDC: 0310-0657

Proprietary Name: Lynparza

Non Proprietary Name: olaparib

Active Ingredient(s):
  • 50 mg/1 OLAPARIB

Administration Route(s): ORAL

Dosage Form(s): CAPSULE

Pharmacy Class(es):
  • Poly(ADP-Ribose) Polymerase Inhibitor [EPC];
  • Poly(ADP-Ribose) Polymerase Inhibitors [MoA]

Labeler Information

Labeler Name: AstraZeneca Pharmaceuticals LP
FDA Application Number: NDA206162
Marketing Category: NDA
Start Marketing Date:12/24/2014
End Marketing Date:3/31/2020

Package Information

No. Package Code Package Description Billing Unit
10310-0657-58112 CAPSULE in 1 BOTTLE (0310-0657-58)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0310-0657The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMELynparzaThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEolaparibThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECAPSULEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE12/24/2014This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE3/31/2020This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA206162This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEAstraZeneca Pharmaceuticals LPName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEOLAPARIBThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESPoly(ADP-Ribose) Polymerase Inhibitor [EPC],Poly(ADP-Ribose) Polymerase Inhibitors [MoA] 

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This page was last updated on: 1/24/2020