Kabiven

{
  "unii": {
    "unii": "OF5P57N2ZX",
    "rxcui": "426",
    "inchikey": "QNAYBMKLOCPYGJ-REOHCLBHSA-N",
    "display_name": "ALANINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "afeb4837-a759-4484-a76e-e04611c459e7": {
      "match": "brand_token",
      "title": "KABIVEN (DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE) INJECTION, EMULSION [FRESENIUS KABI USA, LLC]",
      "spl_version": "9",
      "published_date": "2025-10-06"
    }
  },
  "productid": "63323-712_f4e7d197-8c8f-4603-ae34-cd4c204d89c3",
  "productndc": "63323-712",
  "dosage_form": "INJECTION, EMULSION",
  "orange_book": {
    "appl_no": "200656",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)",
        "product_no": "001",
        "approval_date": "Aug 25, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)",
        "product_no": "002",
        "approval_date": "Aug 25, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)",
        "product_no": "003",
        "approval_date": "Aug 25, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)",
        "product_no": "004",
        "approval_date": "Aug 25, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)",
        "product_no": "005",
        "approval_date": "Aug 25, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML)",
        "product_no": "006",
        "approval_date": "Aug 25, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)",
        "product_no": "007",
        "approval_date": "Aug 25, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALANINE; ARGININE; ASPARTIC ACID; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; METHIONINE; PHENYLALANINE; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; SOYBEAN OIL; THREONINE; TRYPTOPHAN; TYROSINE; VALINE",
  "proprietary_name": "Kabiven",
  "active_ingred_unit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
  "application_number": "NDA200656",
  "marketing_category": "NDA",
  "nonproprietary_name": "Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine",
  "start_marketing_date": "20140825",
  "active_numerator_strength": "467; 330; 99; 29; 10.8; 164; 231; 199; 164; 231; 263; 96; 164; 231; 174; 199; 131; 239; 147; 3.9; 164; 55; 6.7; 213"
}