PRIMAXIN

{
  "unii": {
    "unii": "5428WXZ74M",
    "rxcui": "82128",
    "inchikey": "QXPBTTUOVWMPJN-QBNHLFMHSA-M",
    "display_name": "CILASTATIN SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "f41d8abd-7792-4918-1b93-bd83ea01955e": {
      "match": "brand_token",
      "title": "PRIMAXIN IV (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [MERCK SHARP & DOHME LLC]",
      "spl_version": "34",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0006-3516_34854f9b-7be0-4bfb-8cd2-40baf206fb80",
  "productndc": "0006-3516",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "050587",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Nov 26, 1985"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 500MG BASE/VIAL;500MG/VIAL",
        "product_no": "002",
        "approval_date": "Nov 26, 1985"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CILASTATIN SODIUM; IMIPENEM",
  "proprietary_name": "PRIMAXIN",
  "active_ingred_unit": "mg/100mL; mg/100mL",
  "application_number": "NDA050587",
  "marketing_category": "NDA",
  "nonproprietary_name": "imipenem and cilastatin sodium",
  "start_marketing_date": "19851126",
  "active_numerator_strength": "500; 500"
}