{
  "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": "2026-08-11",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Oracit Citric Acid and Sodium Citrate CITRIC ACID MONOHYDRATE ANHYDROUS CITRIC ACID TRISODIUM CITRATE DIHYDRATE ANHYDROUS CITRIC ACID ALCOHOL METHYLPARABEN PROPYLPARABEN"
      ],
      "spl_unclassified_section": [
        "Rx Only",
        "CMP Pharma, Inc. Post Office Box 147 Farmville, North Carolina 27828 Revised December 2022 3082 R1222 Copyright © CMP Pharma, Inc. 2016"
      ],
      "description": [
        "DESCRIPTION The product is a clear, colorless solution containing Citric Acid USP 640 mg/5 mL, and Hydrous Sodium Citrate USP 490 mg/5 mL. It also contains Methylparaben NF and Propylparaben NF as preservatives. These concentrations yield 1 mEq of sodium, equivalent to 1 mEq of bicarbonate per mL of solution."
      ],
      "clinical_pharmacology": [
        "ACTION Oral citrate solution is used as a systemic and urinary alkalinizer. Less than 5% of the citrate is excreted in the urine unchanged, since citrate oxidation is to a great extent complete."
      ],
      "indications_and_usage": [
        "INDICATIONS ORACIT ® is indicated for the treatment of metabolic acidosis. This solution is also useful in conditions where long term maintenance of alkaline urine is needed (e.g. uric acid and cystine calculi of the urinary tract). ORACIT ® is also effective in treatment for acidosis of certain renal tubular disorders."
      ],
      "contraindications": [
        "CONTRAINDICATIONS ORACIT ® is contraindicated in patients with severe renal impairment, oliguria or azotemia, untreated Addison's disease, adynamia episodica hereditaria, acute dehydration, heat cramp, anuria, severe myocardial damage, and hyperkalemia."
      ],
      "precautions": [
        "PRECAUTIONS The citrate solution should be used with caution in patients with impaired renal function to avoid hypernatremia or alkalosis in the presence of hypocalcemia. Periodic determinations of serum electrolyte levels (especially bicarbonate levels) should be done in patients with renal disease to avoid cardiac failure, hypertension, peripheral and pulmonary edema, and toxemia of pregnancy. The solution should be diluted with water and preferably taken after meals to avoid saline laxative effects."
      ],
      "adverse_reactions": [
        "ADVERSE REACTIONS Citrate solution is generally well tolerated when given in recommended doses when the patient has normal renal functions. To report suspected adverse reactions, contact CMP Pharma, Inc., toll free at 1-844-321-1443 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."
      ],
      "dosage_and_administration": [
        "DOSAGE AND ADMINISTRATION The dose of ORACIT ® is 10 to 30 mL, diluted with water, after meals and at bedtime. The dose should be titrated to achieve desired effects."
      ],
      "how_supplied": [
        "HOW SUPPLIED ORACIT ® is supplied in 500 mL bottles (NDC 46287-014-01), 30 mL unit dose bottles, 10 bottles per carton (NDC 46287-014-30), and 15 mL unit dose bottles, 10 bottles per carton (NDC 46287-014-15). PHARMACIST Dispense in well-closed containers. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]."
      ],
      "storage_and_handling": [
        "Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label NDC 46287-014-01 500 mL Oracit ® ORAL CITRATE (SHOHL'S) SOLUTION CONTAINS: Hydrous Sodium Citrate USP 490 mg/5 mL; Citric Acid USP 640 mg/5 mL; Methylparaben NF; Propylparaben NF; Alcohol USP 0.25%. USUAL DOSAGE: See package insert. Dispense in a well-closed container. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. GTIN: 00346287014010 Rx Only cmp PHARMA Farmville, NC 27828 3050 R1017 PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label"
      ],
      "set_id": "bc26abed-8e6e-475d-8ab3-abf7d0377003",
      "id": "8691f6bc-18e9-4336-8e10-c702ecace00a",
      "effective_time": "20231207",
      "version": "5",
      "openfda": {
        "brand_name": [
          "Oracit"
        ],
        "generic_name": [
          "CITRIC ACID AND SODIUM CITRATE"
        ],
        "manufacturer_name": [
          "CMP Pharma, Inc."
        ],
        "product_ndc": [
          "46287-014"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CITRIC ACID MONOHYDRATE",
          "TRISODIUM CITRATE DIHYDRATE"
        ],
        "rxcui": [
          "544550",
          "544553"
        ],
        "spl_id": [
          "8691f6bc-18e9-4336-8e10-c702ecace00a"
        ],
        "spl_set_id": [
          "bc26abed-8e6e-475d-8ab3-abf7d0377003"
        ],
        "package_ndc": [
          "46287-014-01",
          "46287-014-30",
          "46287-014-15"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0346287014010"
        ],
        "unii": [
          "2968PHW8QP",
          "B22547B95K"
        ]
      }
    }
  ]
}