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United States · US · US:84508-001_7eb8aecb-fbb5-4a6c-a8df-5165dddeaf05
Bicalutamide
Orange BookUNIISPLATC L02BB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPINNACLE LIFE SCIENCE PRIVATE LIMITED
CountryUS (United States)
ATC codeL02BB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc118450800101100 TABLET in 1 BOTTLE (84508-001-01)
- ndc11845080013030 TABLET in 1 BOTTLE (84508-001-30)
Annotations
UNII (FDA Substance ID)
A0Z3NAU9DP
BICALUTAMIDE
RxCUI 83008
Orange Book
A079089
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": {
"26e30155-a50b-df14-e063-6394a90a9be4": {
"match": "brand_token",
"title": "BICALUTAMIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]",
"spl_version": "3",
"published_date": "2026-05-11"
}
},
"productid": "84508-001_7eb8aecb-fbb5-4a6c-a8df-5165dddeaf05",
"productndc": "84508-001",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "079089",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Jul 6, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BICALUTAMIDE",
"proprietary_name": "Bicalutamide",
"active_ingred_unit": "mg/1",
"application_number": "ANDA079089",
"marketing_category": "ANDA",
"nonproprietary_name": "Bicalutamide",
"start_marketing_date": "20090607",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L02BB03.
- CAACH-BICALUTAMIDEACCORD HEALTHCARE INC
- 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
- CZBICALUPLEXTeva Pharmaceuticals CR, s.r.o., Praha
- CZBICALUPLEXTeva Pharmaceuticals CR, s.r.o., Praha
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