Physiosol
PHYSIOSOL IRRIGATION
Approved
Approval ID
c1dba90e-4de9-4488-9be3-64a6ac5f8d93
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 6, 2022
Manufacturers
FDA
ICU Medical Inc.
DUNS: 118380146
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0990-6141
Application NumberNDA017637
Product Classification
M
Marketing Category
C73594
G
Generic Name
SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDE
Product Specifications
Route of AdministrationIRRIGATION
Effective DateJanuary 6, 2022
FDA Product Classification
INGREDIENTS (7)
SODIUM ACETATE ANHYDROUSActive
Quantity: 222 mg in 100 mL
Code: NVG71ZZ7P0
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 526 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
SODIUM GLUCONATEActive
Quantity: 502 mg in 100 mL
Code: R6Q3791S76
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 37 mg in 100 mL
Code: 660YQ98I10
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 30 mg in 100 mL
Code: 02F3473H9O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT