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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

  • ndc11
    4733548508
    100 TABLET, FILM COATED in 1 BOTTLE (47335-485-08)
  • ndc11
    4733548518
    1000 TABLET, FILM COATED in 1 BOTTLE (47335-485-18)
  • ndc11
    4733548583
    30 TABLET, FILM COATED in 1 BOTTLE (47335-485-83)
  • ndc11
    4733548588
    100 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

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