Back to search
🇺🇸

United States · US · US:63629-8308_01c32f48-8661-4d25-8e50-c6c97180cc42

Bicalutamide

Orange BookUNIISPLATC L02BB03

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeL02BB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6362983081
    30 TABLET in 1 BOTTLE (63629-8308-1)
  • ndc11
    6362983082
    100 TABLET in 1 BOTTLE (63629-8308-2)

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": "63629-8308_01c32f48-8661-4d25-8e50-c6c97180cc42",
  "productndc": "63629-8308",
  "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

Other records sharing ATC code L02BB03.

Access this data programmatically

Query Bicalutamide and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.