Abiraterone

Orange BookUNIISPLATC L02BX03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeL02BX03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7278921398
120 TABLET in 1 BOTTLE, PLASTIC (72789-213-98)

Annotations

UNII (FDA Substance ID)

EM5OCB9YJ6

ABIRATERONE ACETATE

RxCUI 1100071

Orange Book

A208339

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "EM5OCB9YJ6",
    "rxcui": "1100071",
    "inchikey": "UVIQSJCZCSLXRZ-UBUQANBQSA-N",
    "display_name": "ABIRATERONE ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "5108c2fe-9706-c976-e063-6294a90a796d": {
      "match": "brand_token",
      "title": "ABIRATERONE ACETATE TABLET [AVPAK]",
      "spl_version": "1",
      "published_date": "2026-05-06"
    }
  },
  "productid": "72789-213_40ac0f51-34ed-e949-e063-6294a90a2366",
  "productndc": "72789-213",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208339",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Oct 31, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ABIRATERONE ACETATE",
  "proprietary_name": "Abiraterone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208339",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Abiraterone acetate",
  "start_marketing_date": "20181123",
  "active_numerator_strength": "250"
}

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