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United States · US · US:59676-600_8d917bea-59a6-4338-b818-6ad5c62d02f9
ERLEADA
Orange BookUNIISPLATC L02BB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJanssen Products, LP
CountryUS (United States)
ATC codeL02BB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115967660012120 TABLET, FILM COATED in 1 BOTTLE (59676-600-12)
- ndc1159676600562 BLISTER PACK in 1 CARTON (59676-600-56) / 28 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
4T36H88UA7
APALUTAMIDE
RxCUI 1999574
Orange Book
N210951
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4T36H88UA7",
"rxcui": "1999574",
"inchikey": "HJBWBFZLDZWPHF-UHFFFAOYSA-N",
"display_name": "APALUTAMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"d1cda4f7-cb33-46ea-b9ac-431f6452b1a5": {
"match": "brand_token",
"title": "ERLEADA (APALUTAMIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]",
"spl_version": "28",
"published_date": "2026-03-16"
}
},
"productid": "59676-600_8d917bea-59a6-4338-b818-6ad5c62d02f9",
"productndc": "59676-600",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "210951",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "60MG",
"product_no": "001",
"approval_date": "Feb 14, 2018"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "240MG",
"product_no": "002",
"approval_date": "Feb 17, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "APALUTAMIDE",
"proprietary_name": "ERLEADA",
"active_ingred_unit": "mg/1",
"application_number": "NDA210951",
"marketing_category": "NDA",
"nonproprietary_name": "Apalutamide",
"start_marketing_date": "20180214",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code L02BB05.
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