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United States · US · US:63323-714_40a5c387-1b0a-4e8e-94e1-f045d7281b0b

Perikabiven

Orange BookUNIISPLATC B05XB

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeB05XB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6332371414
    1440 mL in 1 BAG (63323-714-14)
  • ndc11
    6332371419
    1920 mL in 1 BAG (63323-714-19)

Annotations

UNII (FDA Substance ID)
OF5P57N2ZX
ALANINE
RxCUI 426
Orange Book
N200656
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "OF5P57N2ZX",
    "rxcui": "426",
    "inchikey": "QNAYBMKLOCPYGJ-REOHCLBHSA-N",
    "display_name": "ALANINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "c2eb5522-8572-45f4-869d-42f9fd251bb6": {
      "match": "brand_token",
      "title": "PERIKABIVEN (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": "63323-714_40a5c387-1b0a-4e8e-94e1-f045d7281b0b",
  "productndc": "63323-714",
  "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": "Perikabiven",
  "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": "333; 235; 71; 20; 7.5; 116; 164; 141; 116; 164; 187; 68; 116; 164; 124; 141; 94; 170; 105; 3.5; 116; 40; 4.8; 152"
}

Related drugs

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