Sodium Chloride 0.9%
Status
FDA-approved. Sodium Chloride Injection, USP 0.9% in small single-dose containers is FDA-approved and labeled Rx only: for example Hospira's NDA 018803, whose DailyMed label (set ID 8dfb05c0-77e8-2fa1-e053-2a95a90a3d33) describes a preservative-free product indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to the instructions of the drug's manufacturer. Bacteriostatic Sodium Chloride 0.9% (for example NDA 018800) is a separate product containing benzyl alcohol and is labeled as unsuitable for neonates. Large-volume 0.9% infusions for fluid and electrolyte replacement are different products with their own labels. Checked 25 October 2026.
What it is
Sterile saline used as a diluent for some preparations.
What published research measured
Sodium chloride 0.9 per cent, isotonic with plasma, the standard diluent for parenteral preparations and the reference point against which the hypotonicity of plain sterile water is judged. Its clinical literature concerns volume resuscitation rather than its use as a diluent, and the notable finding there is that large-volume normal saline produces hyperchloraemic metabolic acidosis relative to balanced crystalloids — a consideration for litres of infusion and not for reconstitution volumes. As a diluent it is pharmacologically inert. Preserved multi-dose presentations contain benzyl alcohol and carry the same neonatal contraindication as bacteriostatic water; single-dose presentations do not.
Source
FDA labeling for sodium chloride injection 0.9 per cent
Sources
No linked primary source is on file for this entry yet.
Educational use only, never medical advice. No doses.