Sterile Water

FDA Drug Profile — Sterile Water, STERILE DILUENT

Sterile Water is listed in the FDA National Drug Code directory with 7 NDC codes, marketed under brand names including Sterile Water, STERILE DILUENT. Available dosage forms: injection, solution, irrigant, injection, solution.

Drug Details

Generic Name
Sterile Water
Brand Names
Sterile Water, STERILE DILUENT
Application Number
ANDA212735
Sponsor
Hikma Pharmaceuticals USA Inc.
NDC Codes
7
Dosage Forms
INJECTION, SOLUTION, IRRIGANT, INJECTION, SOLUTION
Routes
INTRAVENOUS, IRRIGATION, INTRAMUSCULAR, SUBCUTANEOUS
Active Ingredients
WATER

Indications and Usage

INDICATIONS & USAGE This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

Warnings

WARNINGS Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis.