bivalirudin

{
  "unii": {
    "unii": "TN9BEX005G",
    "rxcui": "60819",
    "inchikey": null,
    "display_name": "BIVALIRUDIN",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "19a4afc5-151d-4d3c-bfef-48aa8797d695": {
      "match": "brand_token",
      "title": "BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CIVICA, INC.]",
      "spl_version": "2",
      "published_date": "2025-09-15"
    }
  },
  "productid": "70436-025_c44f8757-1a09-ab1e-e053-2a95a90a44e1",
  "productndc": "70436-025",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "213078",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "250MG/VIAL",
        "product_no": "001",
        "approval_date": "May 28, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BIVALIRUDIN",
  "proprietary_name": "bivalirudin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213078",
  "marketing_category": "ANDA",
  "nonproprietary_name": "bivalirudin",
  "start_marketing_date": "20210630",
  "active_numerator_strength": "250"
}