What sizes does sterile water for injection come in?
The FDA National Drug Code Directory returns 18 sterile water entries listing 20 presentations, from 0.5 mL glass syringes to 1000 mL bags. The label language changes at the litre bag.
| Fill volume | Format | Labeler |
|---|---|---|
| 0.5 mL | glass syringe | ROVI Pharma Industrial Services |
| 0.7 mL | syringe, and single-dose vial | Merck Sharp & Dohme |
| 1 mL | plastic syringe | Medefil |
| 1 mL | syringe | Novo Nordisk |
| 1.05 mL | glass syringe | ROVI Pharma |
| 1.16 mL | glass syringe | ROVI Pharma |
| 2.18 mL | glass syringe | ROVI Pharma |
| 2.5 mL | plastic syringe | Medefil |
| 3 mL | plastic syringe | Medefil |
| 5 mL | plastic syringe | Medefil |
| 5 mL | glass syringe | ROVI Pharma |
| 5 mL | plastic vial | Nephron Pharmaceuticals |
| 5 mL | single-dose vial | Chartwell RX |
| 5.2 mL | glass syringe | ROVI Pharma |
| 10 mL | plastic syringe | Medefil |
| 10 mL | plastic vial | HF Acquisition (HealthFirst) |
| 20 mL | plastic vial | HF Acquisition |
| 50 mL | plastic vial | HF Acquisition |
| 100 mL | glass vial | HF Acquisition |
| 1000 mL | bag | Hikma Pharmaceuticals |
The directory was queried 2026-08-07. It is a census of registrations, not a claim about what any supplier stocks. B. Braun's 2000 mL and 3000 mL sterile water entries carry the dosage form IRRIGANT, not injection; they are Sterile Water for Irrigation, a different product with its own USP monograph whose FDA-approved label prints "For Irrigation only. Not for injection or infusion by usual parenteral routes." See sterile water for injection vs. irrigation for the irrigation exclusion and Baxter's bag label.
Label text splits by sterile water vial sizes
Two different DESCRIPTION texts appear on DailyMed labels. Which one a label carries tracks the size of the container.
Small containers — syringes and vials
HealthFirst's 10 mL plastic vial and its 100 mL glass vial carry the same DESCRIPTION verbatim:
"This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection."
Medefil's prefilled-syringe label carries that same text word for word. It is cited on bacteriostatic water vs. sterile water.
The litre bag
Hikma's 1000 mL bag carries a different DESCRIPTION verbatim:
"Sterile Water for Injection, USP, is sterile, nonpyrogenic, distilled water in a single dose container for intravenous administration after addition of a suitable solute. It may also be used as a dispensing container for diluent use. No antimicrobial or other substance has been added. The pH is 5.5 (5.0 to 7.0). The osmolarity is 0."
Baxter's 1000 mL VIAFLEX label carries that sentence word for word; it is cited on sterile water for injection vs. irrigation. Two manufacturers on the small side use one wording, two on the litre side use the other. The difference stands as quoted.
The 5 mL listed twice
Medefil's HOW SUPPLIED table lists two separate 5 mL rows, distinguished by asterisks, with the footnotes printed verbatim as *in 6 mL Syringe and **in 12 mL Syringe. The same 5 mL fill is supplied in a 6 mL barrel and in a 12 mL barrel, under different NDCs. That is why the directory lists 5 mL twice under one product NDC, which would otherwise look like a duplicate record. The same fill-volume-versus-container-size distinction drives sharps container sizes in a different product class. Medefil's label carries no vials; every presentation is a single-dose prefilled syringe.
Two markets inside one census
Merck's 0.7 mL sterile water is not a standalone product. It appears inside the combined label for M-M-R II, whose DailyMed title reads verbatim: "M-M-R II- measles, mumps, and rubella virus vaccine live injection, powder, lyophilized, for suspension STERILE DILUENT- sterile water injection". That is why a 0.7 mL entry exists in the directory.
ROVI's 1.05, 1.16, 2.18 and 5.2 mL glass syringes have the same shape — volumes specified to two decimal places, which general-purpose sizes are not — but no retrieved source confirms what each is packaged with. Some listed volumes belong to standalone products. At least one belongs inside another product's label. The oddly specific figures are not explained by any source retrieved.
Every entry is a prescription drug product identified by an NDC, and a retail listing would have to carry that NDC to match a row.
Sources
- FDA National Drug Code Directory, via openFDA — the sterile water query (queried 2026-08-07)
- DailyMed — STERILE WATER INJECTION [HF Acquisition Co LLC, dba HealthFirst], 10 mL plastic vial — DailyMed record
- DailyMed — STERILE WATER INJECTION [HF Acquisition Co. LLC, dba HealthFirst], 100 mL glass vial — DailyMed record
- DailyMed — STERILE WATER INJECTION, SOLUTION [Hikma Pharmaceuticals USA Inc.], 1000 mL bag — DailyMed record
- DailyMed — M-M-R II … STERILE DILUENT [Merck Sharp & Dohme] — DailyMed record
Specifications last verified: