FDA.reportPublic FDA data

ERLEADA

Product NDC
59676-604
11-digit product format
596760604
Labeler code
59676
Product ID
59676-604_8d917bea-59a6-4338-b818-6ad5c62d02f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Apalutamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Janssen Products, LP
Application
NDA210951
Marketing category
NDA
Marketing start
2018-02-14
Substance
APALUTAMIDE
Active strength
240 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ERLEADA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APALUTAMIDE240 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4T36H88UA7
Rxcui1999581, 1999587, 2630215, 2630217

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e642a8ac-f854-4f01-9fba-01eef6be7381Product name320260105

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59676-604-14ERLEADA1 in 1 CARTONTABLET, FILM COATED128
59676-604-14ERLEADA14 in 1 BLISTER PACKTABLET, FILM COATED1428
59676-604-30ERLEADA30 in 1 BOTTLETABLET, FILM COATED3028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59676-604-30EA - Each59676-6048d1f0756-fb2d-468a-8ae9-bbbe3afb668012023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59676-604ERLEADA (APALUTAMIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]26Current NDC, 3 package rows20250406_d1cda4f7-cb33-46ea-b9ac-431f6452b1a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2630215apalutamide 240 MG Oral TabletPSNd1cda4f7-cb33-46ea-b9ac-431f6452b1a528
1999581apalutamide 60 MG Oral TabletPSNd1cda4f7-cb33-46ea-b9ac-431f6452b1a528
2630217Erleada 240 MG Oral TabletPSNd1cda4f7-cb33-46ea-b9ac-431f6452b1a528
1999587Erleada 60 MG Oral TabletPSNd1cda4f7-cb33-46ea-b9ac-431f6452b1a528
2630217apalutamide 240 MG Oral Tablet [Erleada]SBDd1cda4f7-cb33-46ea-b9ac-431f6452b1a528
1999587apalutamide 60 MG Oral Tablet [Erleada]SBDd1cda4f7-cb33-46ea-b9ac-431f6452b1a528
2630215apalutamide 240 MG Oral TabletSCDd1cda4f7-cb33-46ea-b9ac-431f6452b1a528
1999581apalutamide 60 MG Oral TabletSCDd1cda4f7-cb33-46ea-b9ac-431f6452b1a528
2630217Erleada 240 MG Oral TabletSYd1cda4f7-cb33-46ea-b9ac-431f6452b1a528
1999587Erleada 60 MG Oral TabletSYd1cda4f7-cb33-46ea-b9ac-431f6452b1a528

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59676-604-14596760604141 BLISTER PACK in 1 CARTON (59676-604-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2023-02-17YesNoCurrent
59676-604-305967606043030 TABLET, FILM COATED in 1 BOTTLE (59676-604-30) 2023-02-17NoNoCurrent