Sterile Water 1 mL/mL Injection — NDC 63323-185-10 (Billing 63323-0185-10)
This is a package of Sterile Water 1 mL/mL Injection from Fresenius Kabi USA, LLC, marketed since Sep 2000 and currently FDA-listed; retail pharmacies pay about $0.3150 per mL (NADAC). It is the main listing for this product, which comes in 4 package sizes.
NDC database record
One package, one record: these facts belong to NDC 63323-185-10 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 63323 labeler · 185 product · 10 package
- Package marketed since
- Sep 5, 2000
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0363323185084, 0363323185077, 0363323185046
- Medicaid fills, this package
- 5,706 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Other active recalls for Water (different manufacturers) — 3 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 001167
- GCN: 02709
- GPI-14 (Medi-Span): 98401010002000
- HICL (First Databank): 000517
- AHFS class code: 96:00.00.00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
- It can seem a little odd at first. In these products, sterile water plays the essential role of carrying or dissolving the actual active medication — like insulin — so it can be sa...
- Why is 'water' listed as the active ingredient on my medicine?
- No — these are very different products that should never be used interchangeably. Sterile Water for Injection is used only as a diluent for other drugs given by needle, and it must...
- Is Sterile Water for Injection the same as the eye wash or the irrigation product?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.315 | $78.75 / 250 ml |
| Medicaid paysCMS SDUD · 12 mo | $5.87 | $1,467.80 / 250 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · A4216 | No ASP payment limit on file for A4216 this quarter. | |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Sep 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 63323-0185-05 63323-185-05 | 25 VIAL, SINGLE-DOSE in 1 TRAY / 5 mL in 1 VIAL, SINGLE-DOSE | — | — | 2022-04-30 | — | Active |
| 63323-0185-10 You're viewing this Main listing | 25 VIAL in 1 TRAY / 10 mL in 1 VIAL | $0.3150 / mL | $78.75 | 2000-09-05 | — | Active |
| 63323-0185-20 63323-185-20 | 25 VIAL in 1 TRAY / 20 mL in 1 VIAL | $0.0661 / mL | $33.03 | 2000-09-05 | — | Active |
| 63323-0185-50 63323-185-50 | 25 VIAL in 1 TRAY / 50 mL in 1 VIAL | — | — | 2000-09-05 | — | Active |
Per mL, this pack runs about 377% above the cheapest pack (NDC 63323-0185-20, $0.0661 vs $0.3150 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 80% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Sterile Water 1 mL/mL Injection?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sterile Water 1 mL/mLthis 63323-0185-10 | Fresenius | 25 vials | $0.315 | AP | Availability likely | — |
| Sterile Water 1 mL/mL 00409-4887-10 | Hospira, | 25 vials | $0.315 | — | Availability likely | — |
| Sterile Water 1 mL/mL 00409-0024-10 | Hospira, | 25 vials | $0.315 | — | Availability likely | — |
| Sterile Water 1 mL/mL 65219-0187-10 | Fresenius | 25 vials | — | AP | FDA listed | — |
| Sterile Water 1 mL/mL 76420-0082-10 | Asclemed | 10 ml | — | — | FDA listed | — |
| Bacteriostatic Water 1 mL/mL 71872-7129-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Sterile Water 1 mL/mL 72572-0747-10 | Civica, | 10 vials | — | AP | FDA listed | — |
| Sterile Water 1 mL/mL 00404-9971-00 | Henry | 1 vial | — | — | FDA listed | — |
| Sterile Water 1 mL/mL 50090-2874-01 | A-S | 25 vials | — | — | FDA listed | — |
| Sterile Water 1 mL/mL 55154-9588-05 | Cardinal | 5 vials | — | AP | FDA listed | — |
| Sterile Water 1 mL/mL 00641-6147-10 | Hikma | 10 vials | — | AP | FDA listed | — |
| Sterile Water 1 mL/mL 00404-9959-10 | Henry | 1 vial | — | — | FDA listed | — |
| Sterile Water 1 mL/mL 55154-0127-05 | Cardinal | 5 vials | — | — | FDA listed | — |
| Sterile Water 1 mL/mL 84549-0887-50 | ProPharma | 50 ml | — | — | FDA listed | — |
| Bacteriostatic Water 1 mL/mL 00404-9970-30 | Henry | 1 vial | — | AP | FDA listed | — |
| Sterile Water 1 mL/mL 71872-7290-01 | Medical | 1 vial | — | — | FDA listed | — |
| Sterile Water 1 mL/mL 70518-4732-01 | REMEDYREPACK | 25 vials | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Water inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Fresenius Kabi USA, LLC labeler code 63323
- Sodium Phosphates SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 276 mg/mL; 142 mg/mL Injection, Solution NDC 63323-170-05
- Carboplatin 10 mg/mL Injection, Solution NDC 63323-172-60
- Gentamicin 10 mg/mL Injection, Solution NDC 63323-173-02
- Sterile Water 1000 mL/1000mL Injection, Solution NDC 63323-178-76
- Pyridoxine Hydrochloride 100 mg/mL Injection, Solution NDC 63323-180-01
- Folic Acid 5 mg/mL Injection, Solution NDC 63323-184-10
- Sodium Chloride 9 mg/mL Injection NDC 63323-186-00
- Fludarabine 25 mg/mL Injection, Solution NDC 63323-192-02
- Irinotecan Hydrochloride 20 mg/mL Injection, Solution NDC 63323-193-52
- Lidocaine 10 mg/mL Injection, Solution NDC 63323-201-02
- Lidocaine 20 mg/mL Injection, Solution NDC 63323-202-02
- VANCOMYCIN HYDROCHLORIDE 750 mg/15mL Injection, Powder, Lyophilized, For Solution NDC 63323-203-20
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND 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.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
⛔ Contraindications ▾
CONTRAINDICATIONS Sterile Water for Injection must be made approximately isotonic prior to use.
⚠️ Warnings ▾
WARNINGS Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.
🔄 Drug Interactions ▾
Drug Interactions Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available. Use aseptic technique for single or multiple entry and withdrawal from all containers.
When diluting or dissolving drugs, mix thoroughly and use promptly. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Do not use unless the solution is clear and seal intact.
Do not reuse single-dose containers. Discard unused portion.
🤰 Pregnancy ▾
Pregnancy Animal reproduction studies have not been conducted with Sterile Water for Injection. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness have been established in pediatric patients. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.
🆘 Overdosage ▾
OVERDOSAGE Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures (see WARNINGS , PRECAUTIONS and ADVERSE REACTIONS ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms.
Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium. The small volume of fluid provided by Sterile Water for Injection, USP when used only as a pharmaceutic aid for diluting or dissolving drugs for parenteral injection, is unlikely to exert a significant effect on fluid balance except possibly in neonates or very small infants.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Product Code Unit of Sale Volume Each 918510 NDC 63323-185-10 Unit of 25 10 mL in a 10 mL vial NDC 63323-185-07 10 mL Single Dose Vial 918520 NDC 63323-185-20 Unit of 25 20 mL in a 20 mL vial NDC 63323-185-08 20 mL Single Dose Vial 918550 NDC 63323-185-50 Unit of 25 50 mL in a 50 mL vial NDC 63323-185-09 50 mL Single Dose Vial 187100 NDC 65219-187-10 Unit of 25 100 mL in a 100 mL vial NDC 65219-187-01 100 mL Single Dose Vial 18505 NDC 63323-185-05 Unit of 25 5 mL in a 6 mL vial NDC 63323-185-04 5 mL Single Dose Vial Packaged in a plastic vial.
Vials are packaged 25 vials per tray. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Single dose use.
No preservative added. Unused portion of vial should be discarded. Use only if solution is clear and seal intact.
📋 Description ▾
DESCRIPTION This preparation is designed solely for parenteral use only after addition to 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. For IV injection, add sufficient amount to a solute to make an approximately isotonic solution. pH 5.0 to 7.0.
Water for Injection, USP is chemically designated H 2 O.
⚠️ Precautions ▾
PRECAUTIONS Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture. Consult the manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving the 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.
Pregnancy Animal reproduction studies have not been conducted with Sterile Water for Injection. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed.
Pediatric Use Safety and effectiveness have been established in pediatric patients. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Drug Interactions Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol.
Consult with pharmacist, if available. Use aseptic technique for single or multiple entry and withdrawal from all containers. When diluting or dissolving drugs, mix thoroughly and use promptly.
Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Do not use unless the solution is clear and seal intact. Do not reuse single-dose containers.
Discard unused portion.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 10 mL Single Dose Vial Label NDC 63323-185-07 918510 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 10 mL Single Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 10 mL Single Dose Vial Label
PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 10 mL Single Dose Vial Tray Label NDC 63323-185-10 918510 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 10 mL Single Dose Vial 25 Vials PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 10 mL Single Dose Vial Tray Label
PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 20 mL Single Dose Vial Label NDC 63323-185-08 918520 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 20 mL Single Dose Vial PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 20 mL Single Dose Vial Label
PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 20 mL Single Dose Vial Tray Label NDC 63323-185-20 918520 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 20 mL Single Dose Vial 25 Vials PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 20 mL Single Dose Vial Tray Label
PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 50 mL Single Dose Vial Label NDC 63323-185-09 918550 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 50 mL Single Dose Vial PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 50 mL Single Dose Vial Label
PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 50 mL Single Dose Vial Tray Label NDC 63323-185-50 918550 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 50 mL Single Dose Vial 25 Vials PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 50 mL Single Dose Vial Tray Label
PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 5 mL Single Dose Vial Label NDC 63323-185-04 18505 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 5 mL Single Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 5 mL Single Dose Vial Label
PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 5 mL Single Dose Tray Label NDC 63323-185-05 18505 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 5 mL Single Dose Vial 25 Vials PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 5 mL Single Dose Tray Label