ERLEADA (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 60 mg Tablet Bottle Label

NDC 59676-600-12

Erleada®
(apalutamide) tablets

60 mg

Each tablet contains 60 mg ofapalutamide.

Rx only

120 Tablets

janssen

PRINCIPAL DISPLAY PANEL -- 60 mg Tablet Bottle Label
(click image for full-size original)
ERLEADA apalutamide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-600
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Apalutamide (Apalutamide) Apalutamide 60 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
Croscarmellose sodium
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)
Magnesium stearate
Microcrystalline cellulose
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
Talc
Titanium dioxide
Product Characteristics
Color GREEN (slightly yellowish to greyish green) Score no score
Shape OVAL (Oblong) Size 17mm
Flavor Imprint Code AR;60
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-600-12 120 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:59676-600-99 120 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:59676-600-56 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 28 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (59676-600-56)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210951 02/14/2018
Labeler — Janssen Products, LP (804684207)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceuticals, Inc. 080236951 API MANUFACTURE (59676-600)
Establishment
Name Address ID/FEI Operations
Johnson & Johnson Private Limited 677603030 ANALYSIS (59676-600)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceutica NV 400345889 API MANUFACTURE (59676-600)
Establishment
Name Address ID/FEI Operations
Janssen Ortho LLC 805887986 MANUFACTURE (59676-600)
Establishment
Name Address ID/FEI Operations
Janssen Cilag SpA 542797928 PACK (59676-600)

Revised: 09/2021 Janssen Products, LP

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