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United States · US · US:71205-577_d8a5e670-a721-42c1-a384-4efe056f3a65

Bicalutamide

Orange BookUNIISPLATC L02BB03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeL02BB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7120557730
    30 TABLET in 1 BOTTLE (71205-577-30)
  • ndc11
    7120557760
    60 TABLET in 1 BOTTLE (71205-577-60)
  • ndc11
    7120557790
    90 TABLET in 1 BOTTLE (71205-577-90)

Annotations

UNII (FDA Substance ID)
A0Z3NAU9DP
BICALUTAMIDE
RxCUI 83008
Orange Book
A078917
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": "71205-577_d8a5e670-a721-42c1-a384-4efe056f3a65",
  "productndc": "71205-577",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078917",
    "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": "ANDA078917",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bicalutamide",
  "start_marketing_date": "20090706",
  "active_numerator_strength": "50"
}

Related drugs

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