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NDC 69656-0103-61 ZEJULA 100 mg/1 Details
ZEJULA 100 mg/1
ZEJULA is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by GlaxoSmithKline LLC. The primary component is NIRAPARIB.
MedlinePlus Drug Summary
Niraparib is 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 stomach) cancer in people who have completely responded or partially responded to other chemotherapy medication(s). It is also used to treat certain types of ovarian, fallopian tube, or peritoneal cancer when the cancer has gotten worse after 3 or more chemotherapy treatments. Niraparib is in a class of medications called poly (ADP-ribose) polymerase (PARP) inhibitors. It works by killing cancer cells.
Related Packages: 69656-0103-61Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Niraparib
Product Information
| NDC | 69656-0103 |
|---|---|
| Product ID | 69656-103_c9d12e85-a660-4183-9522-76d5c8e43cab |
| Associated GPIs | 21535550200120 |
| GCN Sequence Number | 077259 |
| GCN Sequence Number Description | niraparib tosylate CAPSULE 100 MG ORAL |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 43217 |
| HICL Sequence Number | 044177 |
| HICL Sequence Number Description | NIRAPARIB TOSYLATE |
| Brand/Generic | Brand |
| Proprietary Name | ZEJULA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | niraparib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | NIRAPARIB |
| Labeler Name | GlaxoSmithKline LLC |
| Pharmaceutical Class | Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208447 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69656-0103-61 (69656010361)
| NDC Package Code | 69656-103-61 |
|---|---|
| Billing NDC | 69656010361 |
| Package | 30 CAPSULE in 1 BOTTLE (69656-103-61) |
| Marketing Start Date | 2020-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |