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NDC 57894-0050-60 AKEEGA 500; 50 mg/1; mg/1 Details
AKEEGA 500; 50 mg/1; mg/1
AKEEGA is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is ABIRATERONE ACETATE; NIRAPARIB TOSYLATE MONOHYDRATE.
MedlinePlus Drug Summary
Niraparib and abiraterone is used in combination with prednisone to treat a certain type of prostate cancer that has already been treated with other medications and has spread to other parts of the body. Niraparib is in a class of medications called poly (ADP-ribose) polymerase (PARP) inhibitors. It works by killing cancer cells. Abiraterone is in a class of medications called androgen biosynthesis inhibitors. It works by decreasing the amount of certain hormones in the body.
Related Packages: 57894-0050-60Last Updated: 04/21/2024
MedLinePlus Full Drug Details: Niraparib and Abiraterone
Product Information
| NDC | 57894-0050 |
|---|---|
| Product ID | 57894-050_03865989-303a-10fc-e063-6394a90ac80b |
| Associated GPIs | |
| GCN Sequence Number | 085157 |
| GCN Sequence Number Description | niraparib/abiraterone TABLET 50MG-500MG ORAL |
| HIC3 | V18 |
| HIC3 Description | ANTINEOPLASTIC-ENZYME INHIB, ANTIANDROGEN COMB. |
| GCN | 54578 |
| HICL Sequence Number | 049143 |
| HICL Sequence Number Description | NIRAPARIB TOSYLATE/ABIRATERONE ACETATE |
| Brand/Generic | Brand |
| Proprietary Name | AKEEGA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | NIRAPARIB TOSYLATE MONOHYDRATE and ABIRATERONE ACETATE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 500; 50 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ABIRATERONE ACETATE; NIRAPARIB TOSYLATE MONOHYDRATE |
| Labeler Name | Janssen Biotech, Inc. |
| Pharmaceutical Class | Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA216793 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 57894-0050-60 (57894005060)
| NDC Package Code | 57894-050-60 |
|---|---|
| Billing NDC | 57894005060 |
| Package | 1 BOTTLE in 1 CARTON (57894-050-60) / 60 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2023-08-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |