Hemodialysis Grade Sodium Bicarbonate Solution

FDA Drug Profile — QUABIC-300, QUABIC-100

Hemodialysis Grade Sodium Bicarbonate Solution is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand names including QUABIC-300, QUABIC-100. Available dosage form: solution, concentrate.

Drug Details

Generic Name
Hemodialysis Grade Sodium Bicarbonate Solution
Brand Names
QUABIC-300, QUABIC-100
Application Number
Sponsor
Aqua Medica, S.A. de C.V.
NDC Codes
3
Dosage Forms
SOLUTION, CONCENTRATE
Routes
HEMODIALYSIS
Active Ingredients
SODIUM BICARBONATE

Indications and Usage

Use Use oly with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water (standard ISO 13959:2014) IN A RATIO 1:1.23:32.77.

Warnings

Warnings The solution should be transparent and colorless. Do not use if cloudy or with broken seal. If not all of the contents are used, discard the excess. Keep at room temperature.