FDA
Sodium Chloride 0.9%
The FDA lists this product in 14 strengths and forms.
Indications
Sodium Chloride Injection, USP, 0.9% is indicated for:
- Dilution or Dissolving the drugs for intravenous, intramuscular or subcutaneous injections ( 1.1 ).
1.1Dilution or Dissolution of Drugs Sodium Chloride Injection, USP,
0.9% is indicated for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
Contraindications
None
- None
Warnings and precautions
- Consult the drug product manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving drugs to be injected including the route and rate of injection ( 5.1 ).
- Do not use Sodium Chloride Injection, USP, 0.9% if the solution is discolored, cloudy, hazy, or contains a precipitate, or if the syringe is damaged ( 5.1 ).
- For single use only. Discard unused portion ( 5.2 ).
5.1General
When used to dilute drug products, consult the drug product manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving drugs to be injected including the route and rate of injection. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. Do not use Sodium Chloride Injection, USP 0.9% if the solution is discolored, cloudy, hazy, or contains a precipitate, or if the syringe is damaged.
5.2For Single Use Only Re-use
of single-use product creates a potential risk to the user. Contamination of product and/or limited functionality of the syringe may lead to injury, illness or death. Discard any unused portion.
Interactions
Some drugs or injections may be incompatible when combined with 0.9% sodium chloride. Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug, the drug product manufacturer’s instructions or other specific references should be checked for any possible incompatibility with sodium chloride. Consult with a pharmacist, if unsure of compatibility.
At a glance
- Brand name
- Sodium Chloride 0.9%
- Active substance
- sodium chloride
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- Medefil Inc
- Status
- Discontinued
- FDA approval
- 6 Jan 2012
- Application
- NDA202832-005



