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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

  • ndc11
    8450800101
    100 TABLET in 1 BOTTLE (84508-001-01)
  • ndc11
    8450800130
    30 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

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