TIS-U-SOL
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Approved
Approval ID
9da4121f-d62d-4da4-8dfb-0494da16015f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 21, 2014
Manufacturers
FDA
Baxter Healthcare Corporation
DUNS: 005083209
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0338-0190
Application NumberNDA018508
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate
Product Specifications
Route of AdministrationIRRIGATION
Effective DateFebruary 21, 2014
FDA Product Classification
INGREDIENTS (6)
POTASSIUM CHLORIDEActive
Quantity: 40 mg in 100 mL
Code: 660YQ98I10
Classification: ACTIB
POTASSIUM PHOSPHATE, MONOBASICActive
Quantity: 6.25 mg in 100 mL
Code: 4J9FJ0HL51
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 800 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MAGNESIUM SULFATE HEPTAHYDRATEActive
Quantity: 20 mg in 100 mL
Code: SK47B8698T
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEActive
Quantity: 8.75 mg in 100 mL
Code: 70WT22SF4B
Classification: ACTIB