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United States · US · US:0338-0190_313abeef-1c8f-4fb4-9e6d-3b3737102c7e

TIS-U-SOL

Orange BookUNIISPLATC C03CB

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

Identification

ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC codeC03CB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0338019004
    12 BOTTLE, PLASTIC in 1 CARTON (0338-0190-04) / 1000 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
SK47B8698T
MAGNESIUM SULFATE HEPTAHYDRATE
RxCUI 236741
Orange Book
N018508
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "SK47B8698T",
    "rxcui": "236741",
    "inchikey": "WRUGWIBCXHJTDG-UHFFFAOYSA-L",
    "display_name": "MAGNESIUM SULFATE HEPTAHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "IRRIGATION",
  "spl_meta": {
    "9da4121f-d62d-4da4-8dfb-0494da16015f": {
      "match": "brand_token",
      "title": "TIS-U-SOL (SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATE) IRRIGANT [BAXTER HEALTHCARE CORPORATION]",
      "spl_version": "10",
      "published_date": "2026-04-17"
    }
  },
  "productid": "0338-0190_313abeef-1c8f-4fb4-9e6d-3b3737102c7e",
  "productndc": "0338-0190",
  "dosage_form": "IRRIGANT",
  "orange_book": {
    "appl_no": "018508",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML",
        "product_no": "001",
        "approval_date": "Feb 19, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MAGNESIUM SULFATE HEPTAHYDRATE; MONOBASIC POTASSIUM PHOSPHATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
  "proprietary_name": "TIS-U-SOL",
  "active_ingred_unit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
  "application_number": "NDA018508",
  "marketing_category": "NDA",
  "nonproprietary_name": "sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate",
  "start_marketing_date": "19820219",
  "active_numerator_strength": "20; 6.25; 40; 800; 8.75"
}

Related drugs

Other records sharing ATC code C03CB.

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