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United States · US · US:47335-485_3259c219-2548-4ea5-b6ad-e22f249879c7
bicalutamide
Orange BookUNIISPLATC L02BB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeL02BB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc114733548508100 TABLET, FILM COATED in 1 BOTTLE (47335-485-08)
- ndc1147335485181000 TABLET, FILM COATED in 1 BOTTLE (47335-485-18)
- ndc11473354858330 TABLET, FILM COATED in 1 BOTTLE (47335-485-83)
- ndc114733548588100 TABLET, FILM COATED in 1 BOTTLE (47335-485-88)
Annotations
UNII (FDA Substance ID)
A0Z3NAU9DP
BICALUTAMIDE
RxCUI 83008
Orange Book
A079110
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": "47335-485_3259c219-2548-4ea5-b6ad-e22f249879c7",
"productndc": "47335-485",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "079110",
"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": "ANDA079110",
"marketing_category": "ANDA",
"nonproprietary_name": "bicalutamide",
"start_marketing_date": "20141215",
"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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