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NDC 00310-0668-60 Lynparza 100 mg/1 Details
Lynparza 100 mg/1
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.
MedlinePlus Drug Summary
Olaparib tablets are used to help maintain the response of certain types of ovarian (female reproductive organs where eggs are formed), fallopian tube (tube that transports eggs released by the ovaries to the uterus), and peritoneal (layer of tissue that lines the abdomen) cancer in people who have completely responded or partially responded to their first or later chemotherapy treatments. Olaparib tablets are also used to treat certain types of breast cancer that has spread to other parts of the body and has not improved or has worsened after treatment with other therapies. Olaparib tablets are also used to treat a certain type of prostate cancer that has spread to other parts of the body, no longer responds to medical or surgical treatments to lower testosterone levels, and has progressed after treatment with enzalutamide (Xtandi) or abiraterone (Yonsa, Zytiga). Olaparib tablets and capsules are also used to treat ovarian cancer that has not improved or has worsened after treatment with at least three other therapies. Olaparib tablets are also used to help maintain the response of a certain type of pancreatic cancer that has not spread or progressed after the first chemotherapy treatment. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor. It works by killing cancer cells.
Related Packages: 00310-0668-60Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Olaparib
Product Information
NDC | 00310-0668 |
---|---|
Product ID | 0310-0668_5d1fb11d-00fa-48eb-b915-acf9ae26de79 |
Associated GPIs | 21535560000330 |
GCN Sequence Number | 077673 |
GCN Sequence Number Description | olaparib TABLET 100 MG ORAL |
HIC3 | V1Q |
HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
GCN | 43766 |
HICL Sequence Number | 041642 |
HICL Sequence Number Description | OLAPARIB |
Brand/Generic | Brand |
Proprietary Name | Lynparza |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | olaparib |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET, FILM COATED |
Route | ORAL |
Active Ingredient Strength | 100 |
Active Ingredient Units | mg/1 |
Substance Name | OLAPARIB |
Labeler Name | AstraZeneca Pharmaceuticals LP |
Pharmaceutical Class | Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA] |
DEA Schedule | n/a |
Marketing Category | NDA |
Application Number | NDA208558 |
Listing Certified Through | 2024-12-31 |
Package
NDC 00310-0668-60 (00310066860)
NDC Package Code | 0310-0668-60 |
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Billing NDC | 00310066860 |
Package | 60 TABLET, FILM COATED in 1 BOTTLE (0310-0668-60) |
Marketing Start Date | 2017-08-17 |
NDC Exclude Flag | N |
Pricing Information | N/A |