FDA Approves Sodium Chloride Injection (NDA018090)

The U.S. Food and Drug Administration has approved the new drug application NDA018090 for a sodium chloride injection. The product is marketed as Sodium Chloride 0.45% in a plastic container and is administered intravenously. It is an injectable solution containing 450 mg of sodium chloride per 100 mL and is classified as a prescription human drug. ICU Medical Inc. is listed as the manufacturer. The approval references multiple package NDC codes (e.g., 0990-7730-36, 0990-7983-61) and a series of FDA submissions covering manufacturing (CMC) and labeling from 1980 through 1998. This approval expands the portfolio of FDA‑cleared intravenous fluids available for clinical use.