CLINIMIX E

Orange BookUNIISPLATC B05XB

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBaxter Healthcare Company

CountryUS (United States)

ATC codeB05XB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0338702804
4 BAG in 1 CARTON (0338-7028-04) / 2000 mL in 1 BAG (0338-7028-01)

Annotations

UNII (FDA Substance ID)

OF5P57N2ZX

ALANINE

RxCUI 426

Orange Book

N020678

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": {
    "dccff103-8695-400c-a15d-cc2fd078760a": {
      "match": "brand_token",
      "title": "CLINIMIX (LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DEXTROSE) INJECTION [BAXTER HEALTHCARE CORPORATION]",
      "spl_version": "13",
      "published_date": "2025-05-29"
    }
  },
  "productid": "0338-7028_dc7ce216-a4a9-41cf-80e3-5e901b8cecdf",
  "productndc": "0338-7028",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "020678",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2.75%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML",
        "product_no": "001",
        "approval_date": "Mar 26, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2.75%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML",
        "product_no": "002",
        "approval_date": "Mar 26, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2.75%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML",
        "product_no": "005",
        "approval_date": "Mar 26, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4.25%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML",
        "product_no": "008",
        "approval_date": "Mar 26, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4.25%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML",
        "product_no": "009",
        "approval_date": "Mar 26, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4.25%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML",
        "product_no": "011",
        "approval_date": "Mar 26, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4.25%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML",
        "product_no": "012",
        "approval_date": "Mar 26, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML",
        "product_no": "016",
        "approval_date": "Mar 26, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5%;33MG/100ML;15GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML",
        "product_no": "017",
        "approval_date": "Mar 26, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML",
        "product_no": "018",
        "approval_date": "Mar 26, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML",
        "product_no": "019",
        "approval_date": "Mar 26, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5%;33MG/100ML;35GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML",
        "product_no": "021",
        "approval_date": "Mar 26, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALANINE; ARGININE; CALCIUM CHLORIDE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM PHOSPHATE, DIBASIC; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE",
  "proprietary_name": "CLINIMIX E",
  "active_ingred_unit": "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; mg/100mL; mg/100mL; mg/100mL",
  "application_number": "NDA020678",
  "marketing_category": "NDA",
  "nonproprietary_name": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
  "start_marketing_date": "20240715",
  "active_numerator_strength": "880; 489; 33; 10; 438; 204; 255; 311; 247; 51; 170; 238; 261; 289; 213; 297; 77; 179; 77; 17; 247"
}

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