Abiraterone Acetate

Orange BookUNIISPLATC L02BX03

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeL02BX03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378692078
120 TABLET in 1 BOTTLE, PLASTIC (0378-6920-78)

Annotations

UNII (FDA Substance ID)

EM5OCB9YJ6

ABIRATERONE ACETATE

RxCUI 1100071

Orange Book

A208446

ABAB

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": "0378-6920_18e5ffff-c938-46e0-bf7a-1c1ab44e8a6d",
  "productndc": "0378-6920",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208446",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Oct 31, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Dec 14, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ABIRATERONE ACETATE",
  "proprietary_name": "Abiraterone Acetate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208446",
  "marketing_category": "ANDA",
  "nonproprietary_name": "abiraterone acetate",
  "start_marketing_date": "20181121",
  "active_numerator_strength": "250"
}

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