Physiolyte
Y36-002-961 LD-515-2 Package Insert
Approved
Approval ID
19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 26, 2023
Manufacturers
FDA
B. Braun Medical Inc.
DUNS: 002397347
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, and Magnesium Chloride
PRODUCT DETAILS
NDC Product Code0264-2205
Application NumberNDA019024
Marketing CategoryC73594
Route of AdministrationIRRIGATION
Effective DateSeptember 26, 2023
Generic NameSodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, and Magnesium Chloride
INGREDIENTS (7)
SODIUM GLUCONATEActive
Quantity: 0.5 g in 100 mL
Code: R6Q3791S76
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 0.037 g in 100 mL
Code: 660YQ98I10
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 0.53 g in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 0.03 g in 100 mL
Code: 02F3473H9O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEActive
Quantity: 0.37 g in 100 mL
Code: 4550K0SC9B
Classification: ACTIB