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United States · US · US:62559-680_9395c6cd-8f49-423e-839b-0c3aeb89b371
CASODEX
Orange BookUNIISPLATC L02BB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL02BB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11625596803030 TABLET in 1 BOTTLE (62559-680-30)
Annotations
UNII (FDA Substance ID)
A0Z3NAU9DP
BICALUTAMIDE
RxCUI 83008
Orange Book
N020498
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "A0Z3NAU9DP",
"rxcui": "83008",
"inchikey": "LKJPYSCBVHEWIU-UHFFFAOYSA-N",
"display_name": "BICALUTAMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"dfee4fe7-8478-4a3e-925d-00be3cd0ab67": {
"match": "brand_token",
"title": "CASODEX (BICALUTAMIDE) TABLET [ANI PHARMACEUTICALS, INC.]",
"spl_version": "6",
"published_date": "2026-03-05"
}
},
"productid": "62559-680_9395c6cd-8f49-423e-839b-0c3aeb89b371",
"productndc": "62559-680",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "020498",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Oct 4, 1995"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BICALUTAMIDE",
"proprietary_name": "CASODEX",
"active_ingred_unit": "mg/1",
"application_number": "NDA020498",
"marketing_category": "NDA",
"nonproprietary_name": "Bicalutamide",
"start_marketing_date": "20180626",
"active_numerator_strength": "50"
}Related drugs
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- CZBICALUPLEXTeva Pharmaceuticals CR, s.r.o., Praha
- CZBICALUPLEXTeva Pharmaceuticals CR, s.r.o., Praha
- CZBICALUPLEXTeva Pharmaceuticals CR, s.r.o., Praha
- CZBICALUPLEXTeva Pharmaceuticals CR, s.r.o., Praha
- CZBICALUPLEXTeva Pharmaceuticals CR, s.r.o., Praha
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