erleada

Generic: apalutamide

Labeler: janssen products, lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name erleada
Generic Name apalutamide
Labeler janssen products, lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

apalutamide 60 mg/1

Manufacturer
Janssen Products, LP

Identifiers & Regulatory

Product NDC 59676-600
Product ID 59676-600_3e5f0afd-e187-f238-e063-6294a90a8fa7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210951
Listing Expiration 2026-12-31
Marketing Start 2018-02-14

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59676600
Hyphenated Format 59676-600

Supplemental Identifiers

RxCUI
1999581 1999587 2630215 2630217
UNII
4T36H88UA7

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 erleada (source: ndc)
Generic Name apalutamide (source: ndc)
Application Number NDA210951 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (59676-600-12)
  • 2 BLISTER PACK in 1 CARTON (59676-600-56) / 28 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

59676-600-12 120 TABLET, FILM COATED in 1 BOTTLE (59676-600-12) 59676-600-56 2 BLISTER PACK in 1 CARTON (59676-600-56) / 28 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

apalutamide (60 mg/1)

Linked Drug Pages (1)

ERLEADA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3e5f0afd-e187-f238-e063-6294a90a8fa7", "openfda": {"unii": ["4T36H88UA7"], "rxcui": ["1999581", "1999587", "2630215", "2630217"], "spl_set_id": ["d1cda4f7-cb33-46ea-b9ac-431f6452b1a5"], "manufacturer_name": ["Janssen Products, LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (59676-600-12)", "package_ndc": "59676-600-12", "marketing_start_date": "20180214"}, {"sample": true, "description": "2 BLISTER PACK in 1 CARTON (59676-600-56)  / 28 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "59676-600-56", "marketing_start_date": "20190401"}], "brand_name": "ERLEADA", "product_id": "59676-600_3e5f0afd-e187-f238-e063-6294a90a8fa7", "dosage_form": "TABLET, FILM COATED", "product_ndc": "59676-600", "generic_name": "Apalutamide", "labeler_name": "Janssen Products, LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ERLEADA", "active_ingredients": [{"name": "APALUTAMIDE", "strength": "60 mg/1"}], "application_number": "NDA210951", "marketing_category": "NDA", "marketing_start_date": "20180214", "listing_expiration_date": "20261231"}