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United States · US · US:62559-680_9395c6cd-8f49-423e-839b-0c3aeb89b371

CASODEX

Orange BookUNIISPLATC L02BB03

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

Identification

ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL02BB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6255968030
    30 TABLET in 1 BOTTLE (62559-680-30)

Annotations

UNII (FDA Substance ID)
A0Z3NAU9DP
BICALUTAMIDE
RxCUI 83008
Orange Book
N020498
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": {
    "dfee4fe7-8478-4a3e-925d-00be3cd0ab67": {
      "match": "brand_token",
      "title": "CASODEX (BICALUTAMIDE) TABLET [ANI PHARMACEUTICALS, INC.]",
      "spl_version": "6",
      "published_date": "2026-03-05"
    }
  },
  "productid": "62559-680_9395c6cd-8f49-423e-839b-0c3aeb89b371",
  "productndc": "62559-680",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "020498",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Oct 4, 1995"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BICALUTAMIDE",
  "proprietary_name": "CASODEX",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020498",
  "marketing_category": "NDA",
  "nonproprietary_name": "Bicalutamide",
  "start_marketing_date": "20180626",
  "active_numerator_strength": "50"
}

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