{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Lactated Ringers Sodium chloride, potassium chloride, sodium lactate and calcium chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID, UNSPECIFIED FORM POTASSIUM CHLORIDE POTASSIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION WATER Lactated Ringers Sodium chloride, potassium chloride, sodium lactate and calcium chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID, UNSPECIFIED FORM POTASSIUM CHLORIDE POTASSIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION WATER"
      ],
      "health_care_provider_letter": [
        "Health Care Professional Letter Reportin Adverse Events or Product Quality Issues To report adverse events associated with these imported products, please call Baxter at 1-866-888-2472, or fax: 1-800-759-1801. Adverse events or quality problems experienced with the use of these imported products may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, or by regulary mail or by fax: • Complete and submit the report Online : https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program • Regular mail or Fax : Download form https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178) To report product quality issues associated with these imported products, please contact Baxter Product Surveillance through Baxter – Product Feedback Portal ( https://productfeedback.baxter.com/ ). Please refer to the FDA-approved prescribing information for each drug product as follows: • 5% Dextrose Injection, USP (click DailyMed - DEXTROSE- dextrose monohydrate injection, solution ) • 0.9% Sodium Chloride Injection, USP (click DailyMed - SODIUM CHLORIDE injection, solution ) • Lactated Ringers Injection, USP (click DailyMed - LACTATED RINGERS- sodium chloride, potassium chloride, sodium lactate and calcium chloride injection, solution ) • Plasma-Lyte Injection, USP (click DailyMed - PLASMA-LYTE A- sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride injection, solution ) DHCP Letter 1 of 17 DHCP Letter 2 of 17 DHCP Letter 3 of 17 DHCP Letter 4 of 17 DHCP Letter 5 of 17 DHCP Letter 6 of 17 DHCP Letter 7 of 17 DHCP Letter 8 of 17 DHCP Letter 9 of 17 DHCP Letter 10 of 17 DHCP Letter 11 of 17 DHCP Letter 12 of 17 DHCP Letter 13 of 17 DHCP Letter 14 of 17 DHCP Letter 15 of 17 DHCP Letter 16 of 17 DHCP Letter 17 of 17"
      ],
      "package_label_principal_display_panel": [
        "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label JB2324 1000 mL DIN 00061085 Lactated Ringer’s Injection USP Lactate de Ringer USP, Injectable Lactated Ringer Lactate de Ringer APPROX mmol/L Na – 130 K – 4 Ca – 1.4 CI – 109 LACTATE – 28 mOsmol/L – 272 pH 6.5 INTRAVENOUS FLUID AND ELECTROLYTE REPLENISHMENT RETABLISSEMENT HYDRO-ELECTROLYTIQUE PAR INJECTION INTRAVENIEUSE PER 100 mL SODIUM CHLORIDE USP – 600 mg / SODIUM LACTATE – 310 mg / POTASSIUM CHLORIDE USP – 30 mg / CALCIUM CHLORIDE DIHYDRATE USP – 20 mg / WATER FOR INJECTION USP – qs PAR 100 mL CHLORURE DE SODIUM USP – 600 mg / LACTATE DE SO- DIUM – 310 mg / CHLORURE DE POTASSIUM USP – 30 mg / DIHYDRATE DE CHLORURE DE CALCIUM USP – 20 mg / EAU POUR INJECTION USP – qs CAUTIONS SINGLE USE / DISCARD UNUSED PORTION / SQUEEZE AND INSPECT BAG / SEE DIRECTIONS FOR USE / NOT FOR USE IN THE TREATEMENT OF LACTIC ACIDOSIS / MUST NOT BE USED IN SERIES CONNECTIONS / DO NOT ADMINSTER SIMULTANEOUSLY WITH BLOOD STORE AT 15°C TO 25°C ATTENTIONS USAGE UNIQUE / JETER PORTION INUTILISEE / PRESSER ET INSPECTER LE SAC / VOIR MODE D’EMPLOI / NE PAS UTILISER DANS LE TRAITEMENT DE L’ACIDOSE LACTIQUE / NE DOIT PAS ETRE MONTE EN SERIE / NE PAS ADMINISTRER SIMULTANEMENT AVEC LE SANG GARDER ENTRE 15°C ET 25°C NONPYROGENIC / STERILE / APYROGENE VIAFLEX PVC CONTAINER / CONTENANT DE PVC BAXTER AND VIAFLEX ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER ET VIAFLEX SONT DES MARQUES DE COMMERCE DE BAXTER INTERNATIONAL INC Baxter Logo Baxter Corporation Mississauga ON L5N 0C2 No Latex Label 88-70-20-487 1 _ 2 _ 3 _ 4 _ 5 _ 6 _ 7 _ 8 _ 9 Container Label JB2323 500 mL DIN 00061085 Lactated Ringer’s Injection USP Lactate de Ringer USP, Injectable Lactated Ringer Lactate de Ringer APPROX mmol/L Na – 130 K – 4 Ca – 1.4 CI 109 LACTATE – 28 mOsmol/L – 272 pH 6.5 INTRAVENOUS FLUID AND ELECTROLYTE REPLENISHMENT / RETABLISSE- MENT HYDRO-ELECTROLYTIQUE PAR INJECTION INTRAVENIEUSE PER 100 mL SODIUM CHLORIDE USP – 600 mg / SODIUM LACTATE – 310 mb / PO- TASSIUM CHLORIDE USP – 30 mg / CALCIUM CHLORIDE DIHYDRATE USP – 20 mg / WATER FOR INJECTION USP – qs PAR 100 mL CHLORURE DE SODIUM USP – 600 mg / LACTATE DE SODIUM – 310 mg / CHLORURE DE POTASSIUM USP – 30 mg / DIHYDRATE DECHLORURE DE CALCIUM USP – 20 mg / EAU POUR INJECTION USP – qs CAUTIONS SINGLE USE / DISCARD UNUSED PORTION / SQUEEZE AND INSPECT BAG / SEE DIRECTIONS FOR USE / NOT FOR USE IN THE TREATEMENT OF LACTIC ACIDOSIS / MUST NOT BE USED IN SERIES CONNECTIONS / DO NOT ADMINSTER SIMULTANEOUSLY WITH BLOOD STORE AT 15°C TO 25°C ATTENTIONS USAGE UNIQUE / JETER PORTION INUTILISEE / PRESSER ET INSPECT- ER LE SAC / VOIR MODE D’EMPLOI / NE PAS UTILISER DANS LE TRAITEMENT DE L’ACIDOSE LACTIQUE / NE DOIT PAS ETRE MONTE EN SERIE / NE PAS ADMINISTRER SIMULTANEMENT AVEC LE SANG GARDER ENTRE 15°C ET 25°C NONPYROGENIC / STERILE / APYROGENE VIAFLEX PVC CONTAINER / CONTENANT DE PVC BAXTER AND VIAFLEX ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER ET VIAFLEX SONT DES MARQUES DE COMMERCE DE BAXTER INTERNATIONAL INC Baxter Logo Baxter Corporation Mississauga ON L5N 0C2 No Latex Label 07-25-77-062 -1- _ -2- _ -3- _ -4- Container Label NDC 0338-9600-01 Container Label NDC 0338-9596-01"
      ],
      "set_id": "3bbf0dd8-4fbe-4c0d-b82d-02b77f26bec7",
      "id": "b0e51082-3d87-45c2-81c4-411057300b84",
      "effective_time": "20241202",
      "version": "3",
      "openfda": {
        "brand_name": [
          "Lactated Ringers"
        ],
        "generic_name": [
          "SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Company"
        ],
        "product_ndc": [
          "0338-9600",
          "0338-9596"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "CALCIUM CHLORIDE",
          "POTASSIUM CHLORIDE",
          "SODIUM CHLORIDE",
          "SODIUM LACTATE"
        ],
        "rxcui": [
          "847630"
        ],
        "spl_id": [
          "b0e51082-3d87-45c2-81c4-411057300b84"
        ],
        "spl_set_id": [
          "3bbf0dd8-4fbe-4c0d-b82d-02b77f26bec7"
        ],
        "package_ndc": [
          "0338-9600-01",
          "0338-9600-12",
          "0338-9596-01",
          "0338-9596-24"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "M4I0D6VV5M",
          "660YQ98I10",
          "451W47IQ8X",
          "TU7HW0W0QT"
        ]
      }
    }
  ]
}