Potassium Chloride in Dextrose and Sodium Chloride

{
  "unii": {
    "unii": "LX22YL083G",
    "rxcui": "1299920",
    "inchikey": "SPFMQWBKVUQXJV-BTVCFUMJSA-N",
    "display_name": "DEXTROSE MONOHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "ff67f638-5b53-406a-962a-87773a91fc48": {
      "match": "brand_token",
      "title": "POTASSIUM CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2026-05-28"
    }
  },
  "productid": "0990-7901_944f8598-ac1a-45af-a5b4-cdc4ea9656ca",
  "productndc": "0990-7901",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "018365",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "5GM/100ML;149MG/100ML;225MG/100ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5GM/100ML;74.5MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Jul 5, 1983"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5GM/100ML;224MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Jul 5, 1983"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5GM/100ML;298MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Jul 5, 1983"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5GM/100ML;74.5MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "005",
        "approval_date": "Mar 28, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5GM/100ML;149MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "006",
        "approval_date": "Mar 28, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5GM/100ML;149MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "007",
        "approval_date": "Mar 28, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5GM/100ML;224MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "008",
        "approval_date": "Mar 28, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5GM/100ML;298MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "009",
        "approval_date": "Mar 28, 1988"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE",
  "shortage_reason": "Dextrose Monohydrate 5% Injection",
  "shortage_status": "current",
  "proprietary_name": "Potassium Chloride in Dextrose and Sodium Chloride",
  "active_ingred_unit": "g/1000mL; g/1000mL; g/1000mL",
  "application_number": "NDA018365",
  "marketing_category": "NDA",
  "nonproprietary_name": "DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE",
  "start_marketing_date": "20200201",
  "active_numerator_strength": "50; 1.49; 2.25"
}