akeega

Generic: niraparib tosylate monohydrate and abiraterone acetate

Labeler: janssen biotech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name akeega
Generic Name niraparib tosylate monohydrate and abiraterone acetate
Labeler janssen biotech, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

abiraterone acetate 500 mg/1, niraparib tosylate monohydrate 50 mg/1

Manufacturer
Janssen Biotech, Inc.

Identifiers & Regulatory

Product NDC 57894-050
Product ID 57894-050_463bff67-d7cf-a132-e063-6394a90abe1d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216793
Listing Expiration 2026-12-31
Marketing Start 2023-08-11

Pharmacologic Class

Classes
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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57894050
Hyphenated Format 57894-050

Supplemental Identifiers

RxCUI
2645244 2645250 2645251 2645253
UNII
195Q483UZD EM5OCB9YJ6

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name akeega (source: ndc)
Generic Name niraparib tosylate monohydrate and abiraterone acetate (source: ndc)
Application Number NDA216793 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 50 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (57894-050-60) / 60 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

57894-050-60 1 BOTTLE in 1 CARTON (57894-050-60) / 60 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

abiraterone acetate (500 mg/1) niraparib tosylate monohydrate (50 mg/1)

Linked Drug Pages (1)

AKEEGA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "463bff67-d7cf-a132-e063-6394a90abe1d", "openfda": {"unii": ["195Q483UZD", "EM5OCB9YJ6"], "rxcui": ["2645244", "2645250", "2645251", "2645253"], "spl_set_id": ["8245a990-3268-4613-b5c5-9537858a1eb9"], "manufacturer_name": ["Janssen Biotech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (57894-050-60)  / 60 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "57894-050-60", "marketing_start_date": "20230811"}], "brand_name": "AKEEGA", "product_id": "57894-050_463bff67-d7cf-a132-e063-6394a90abe1d", "dosage_form": "TABLET, FILM COATED", "pharm_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]"], "product_ndc": "57894-050", "generic_name": "NIRAPARIB TOSYLATE MONOHYDRATE and ABIRATERONE ACETATE", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AKEEGA", "active_ingredients": [{"name": "ABIRATERONE ACETATE", "strength": "500 mg/1"}, {"name": "NIRAPARIB TOSYLATE MONOHYDRATE", "strength": "50 mg/1"}], "application_number": "NDA216793", "marketing_category": "NDA", "marketing_start_date": "20230811", "listing_expiration_date": "20261231"}