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United States · US · US:51991-005_cb46b87b-4bbc-4aed-8656-877a480061af

Exemestane

Orange BookUNIISPLATC L02BG06

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

Identification

ManufacturerBreckenridge Pharmaceutical, Inc.
CountryUS (United States)
ATC codeL02BG06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5199100590
    90 TABLET, FILM COATED in 1 BOTTLE (51991-005-90)

Annotations

UNII (FDA Substance ID)
NY22HMQ4BX
EXEMESTANE
RxCUI 258494
Orange Book
A211031
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "NY22HMQ4BX",
    "rxcui": "258494",
    "inchikey": "BFYIZQONLCFLEV-DAELLWKTSA-N",
    "display_name": "EXEMESTANE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "69abd0ff-b200-4d1a-b14a-80e980a8e781": {
      "match": "brand_token",
      "title": "EXEMESTANE TABLET, SUGAR COATED [MYLAN PHARMACEUTICALS INC.]",
      "spl_version": "20",
      "published_date": "2025-12-25"
    }
  },
  "productid": "51991-005_cb46b87b-4bbc-4aed-8656-877a480061af",
  "productndc": "51991-005",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211031",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Feb 21, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EXEMESTANE",
  "proprietary_name": "Exemestane",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211031",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Exemestane",
  "start_marketing_date": "20191219",
  "active_numerator_strength": "25"
}

Related drugs

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