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United States · US · US:47335-401_5936666c-b89c-4feb-9146-74877fd9b679

YONSA

Orange BookUNIISPLATC L02BX03

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeL02BX03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4733540181
    120 TABLET in 1 BOTTLE, PLASTIC (47335-401-81)

Annotations

UNII (FDA Substance ID)
EM5OCB9YJ6
ABIRATERONE ACETATE
RxCUI 1100071
Orange Book
N210308
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": {
    "b8967e10-f768-47ce-ac9e-2324c8390132": {
      "match": "brand_token",
      "title": "YONSA (ABIRATERONE ACETATE) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "13",
      "published_date": "2026-05-22"
    }
  },
  "productid": "47335-401_5936666c-b89c-4feb-9146-74877fd9b679",
  "productndc": "47335-401",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210308",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "125MG",
        "product_no": "001",
        "approval_date": "May 22, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ABIRATERONE ACETATE",
  "proprietary_name": "YONSA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA210308",
  "marketing_category": "NDA",
  "nonproprietary_name": "abiraterone acetate",
  "start_marketing_date": "20180522",
  "active_numerator_strength": "125"
}

Related drugs

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