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NDC 00310-0668-95 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 is used alone or in combination with bevacizumab (Avastin) 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 is 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. It is also used to treat certain types of early breast cancer in people who have already been treated with surgery and other chemotherapy treatments. Olaparib is 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). It is also used in combination with abiraterone and prednisone to treat a certain type of prostate cancer that has spread to other parts of the body and no longer responds to medical or surgical treatments to lower testosterone levels. Olaparib is 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: 00310-0668-95Last Updated: 03/24/2024
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 00310-0668-95 (00310066895)
NDC Package Code | 0310-0668-95 |
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Billing NDC | 00310066895 |
Package | 60 TABLET, FILM COATED in 1 BOTTLE (0310-0668-95) |
Marketing Start Date | 2022-09-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |