CLINIMIX

Orange BookUNIISPLATC B05XB

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

Identification

ManufacturerBaxter Healthcare Corporation

CountryUS (United States)

ATC codeB05XB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0338701504
4 BAG in 1 CARTON (0338-7015-04) / 2000 mL in 1 BAG (0338-7015-01)

Annotations

UNII (FDA Substance ID)

OF5P57N2ZX

ALANINE

RxCUI 426

Orange Book

N020734

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": "0338-7015_f39f992f-7a22-46f6-9241-f03d349b95d9",
  "productndc": "0338-7015",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "020734",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2.75%;5GM/100ML",
        "product_no": "001",
        "approval_date": "Sep 29, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2.75%;10GM/100ML",
        "product_no": "002",
        "approval_date": "Sep 29, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2.75%;25GM/100ML",
        "product_no": "005",
        "approval_date": "Sep 29, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "4.25%;5GM/100ML",
        "product_no": "007",
        "approval_date": "Sep 29, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "4.25%;10GM/100ML",
        "product_no": "008",
        "approval_date": "Sep 29, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "4.25%;20GM/100ML",
        "product_no": "010",
        "approval_date": "Sep 29, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "4.25%;25GM/100ML",
        "product_no": "011",
        "approval_date": "Sep 29, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5%;10GM/100ML",
        "product_no": "014",
        "approval_date": "Sep 29, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5%;15GM/100ML",
        "product_no": "015",
        "approval_date": "Sep 29, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5%;20GM/100ML",
        "product_no": "016",
        "approval_date": "Sep 29, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5%;25GM/100ML",
        "product_no": "017",
        "approval_date": "Sep 29, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5%;35GM/100ML",
        "product_no": "018",
        "approval_date": "Sep 29, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "8%;14GM/100ML",
        "product_no": "019",
        "approval_date": "Apr 13, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE",
  "proprietary_name": "CLINIMIX",
  "active_ingred_unit": "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",
  "application_number": "NDA020734",
  "marketing_category": "NDA",
  "nonproprietary_name": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose",
  "start_marketing_date": "20240715",
  "active_numerator_strength": "1035; 575; 20; 515; 240; 300; 365; 290; 200; 280; 340; 250; 210; 90; 20; 290"
}

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