tis-u-sol

Generic: sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tis-u-sol
Generic Name sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate
Labeler baxter healthcare corporation
Dosage Form IRRIGANT
Routes
IRRIGATION
Active Ingredients

magnesium sulfate heptahydrate 20 mg/100mL, monobasic potassium phosphate 6.25 mg/100mL, potassium chloride 40 mg/100mL, sodium chloride 800 mg/100mL, sodium phosphate, dibasic, heptahydrate 8.75 mg/100mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-0190
Product ID 0338-0190_5074eb86-6e17-4bcf-8266-253135c6badf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018508
Listing Expiration 2026-12-31
Marketing Start 1982-02-19

Pharmacologic Class

Classes
calculi dissolution agent [epc] increased large intestinal motility [pe] inhibition large intestine fluid/electrolyte absorption [pe] inhibition small intestine fluid/electrolyte absorption [pe] magnesium ion exchange activity [moa] osmotic activity [moa] osmotic laxative [epc] potassium compounds [cs] potassium salt [epc] stimulation large intestine fluid/electrolyte secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03380190
Hyphenated Format 0338-0190

Supplemental Identifiers

RxCUI
801442 801445
UNII
SK47B8698T 4J9FJ0HL51 660YQ98I10 451W47IQ8X 70WT22SF4B

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tis-u-sol (source: ndc)
Generic Name sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate (source: ndc)
Application Number NDA018508 (source: ndc)
Routes
IRRIGATION
source: ndc

Resolved Composition

Strengths
  • 20 mg/100mL
  • 6.25 mg/100mL
  • 40 mg/100mL
  • 800 mg/100mL
  • 8.75 mg/100mL
source: ndc
Packaging
  • 12 BOTTLE, PLASTIC in 1 CARTON (0338-0190-04) / 1000 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

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

Ingredients (5)

magnesium sulfate heptahydrate (20 mg/100mL) monobasic potassium phosphate (6.25 mg/100mL) potassium chloride (40 mg/100mL) sodium chloride (800 mg/100mL) sodium phosphate, dibasic, heptahydrate (8.75 mg/100mL)

Linked Drug Pages (1)

TIS-U-SOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["IRRIGATION"], "spl_id": "5074eb86-6e17-4bcf-8266-253135c6badf", "openfda": {"unii": ["SK47B8698T", "4J9FJ0HL51", "660YQ98I10", "451W47IQ8X", "70WT22SF4B"], "rxcui": ["801442", "801445"], "spl_set_id": ["9da4121f-d62d-4da4-8dfb-0494da16015f"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BOTTLE, PLASTIC in 1 CARTON (0338-0190-04)  / 1000 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0338-0190-04", "marketing_start_date": "19820219"}], "brand_name": "TIS-U-SOL", "product_id": "0338-0190_5074eb86-6e17-4bcf-8266-253135c6badf", "dosage_form": "IRRIGANT", "pharm_class": ["Calculi Dissolution Agent [EPC]", "Increased Large Intestinal Motility [PE]", "Increased Large Intestinal Motility [PE]", "Increased Large Intestinal Motility [PE]", "Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]", "Magnesium Ion Exchange Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Potassium Compounds [CS]", "Potassium Salt [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "0338-0190", "generic_name": "sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TIS-U-SOL", "active_ingredients": [{"name": "MAGNESIUM SULFATE HEPTAHYDRATE", "strength": "20 mg/100mL"}, {"name": "MONOBASIC POTASSIUM PHOSPHATE", "strength": "6.25 mg/100mL"}, {"name": "POTASSIUM CHLORIDE", "strength": "40 mg/100mL"}, {"name": "SODIUM CHLORIDE", "strength": "800 mg/100mL"}, {"name": "SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE", "strength": "8.75 mg/100mL"}], "application_number": "NDA018508", "marketing_category": "NDA", "marketing_start_date": "19820219", "listing_expiration_date": "20261231"}