Sterile Water 1000 mL/1000mL Injection, Solution — NDC 63323-178-76 (Billing 63323-0178-76)
This is a package of Sterile Water 1000 mL/1000mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since Nov 2017 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 63323-178-76 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 63323 labeler · 178 product · 76 package
- Package marketed since
- Nov 24, 2017
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 6332317876 5
- Medicaid fills, this package
- 346 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): 001166
- GCN: 02729
- 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 | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.0083 | $83.00 / 10000 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
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- 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 | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 63323-0178-76 You're viewing this Main listing | 10 BAG in 1 CASE / 1000 mL in 1 BAG | 2017-11-24 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sterile Water 1000 mL/1000mLthis 63323-0178-76 | Fresenius | 1000 ml | — | AP | FDA listed | — |
| Sterile Water 1000 mL/1000mL 17271-0750-07 | Becton | 1000 ml | — | AP | FDA listed | — |
| Sterile Water 1000 mL/1000mL 00990-7990-09 | ICU | 12 pouches | — | AP | 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
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
- Ketorolac Tromethamine 30 mg/mL Injection, Solution NDC 63323-162-01
- LACTATED RINGERS SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL Injection, Solution NDC 63323-164-74
- Dexamethasone Sodium Phosphate 4 mg/mL Injection, Solution NDC 63323-165-01
- 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
- Pyridoxine Hydrochloride 100 mg/mL Injection, Solution NDC 63323-180-01
- Folic Acid 5 mg/mL Injection, Solution NDC 63323-184-10
- Sterile Water 1 mL/mL Injection NDC 63323-185-05
- 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
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: Sterile Water for Injection is indicated for use only as a solvent or diluent vehicle for parenterally administered drugs or solutions and as a source of water for parenteral fluid replenishment after suitable additives are introduced. For intravenous administration, an osmolar concentration not less than two-fifths (0.4) of the normal osmolarity of the extracellular fluid (280 mOsmol/liter) is essential to avoid intravascular hemolysis.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: Following suitable admixture of prescribed additive, the dose is usually dependent upon the age, weight and clinical condition of the patient. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available.
When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (See PRECAUTIONS ).
⛔ Contraindications ▾
CONTRAINDICATIONS: Do not administer without the addition of a solute.
⚠️ Warnings ▾
WARNINGS: FOR DRUG DILUENT USE ONLY. Intravenous administration of Sterile Water for Injection without additives may result in hemolysis. The intravenous administration of sterile water for injection with additives can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions. WARNING: This product contains aluminum that may be toxic.
Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.
Tissue loading may occur at even lower rates of administration.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: Reactions which may occur because of the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
🤰 Pregnancy ▾
Pregnancy Category C 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 The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. This product contains no more than 25 mcg/L of aluminum.
🆘 Overdosage ▾
OVERDOSAGE: In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures (See WARNINGS ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY: When administered intravenously as a vehicle for drugs, sterile water for injection provides a source of water for parenteral fluid replenishment after sufficient solute is introduced to achieve an osmolarity of 112 mOsmol or more per liter. 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 (1.0 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.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Sterile Water for Injection, USP is supplied in a single dose flexible plastic container as follows: Product No. NDC No. Bag Size Bags Per Carton 917876 63323-178-76 1,000 mL Bag 10 Bags The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.
📋 Description ▾
DESCRIPTION: Sterile Water for Injection, USP is a sterile, nonpyrogenic, solute-free preparation of distilled water for injection. It is for use only as a sterile solvent or diluent vehicle for drugs or solutions suitable for parenteral administration. The pH is 5.5 (5.0 to 7.0).
Sterile Water for Injection contains no bacteriostat, antimicrobial agent or added buffer and is intended only for single dose injection after admixture with an appropriate solute or solution. When smaller amounts are required, the unused portion should be discarded. Sterile Water for Injection is a pharmaceutic aid (vehicle) and parenteral fluid replenisher after addition of an appropriate solute.
Water for Injection, USP is chemically designated H 2 O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly.
Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.
⚠️ Precautions ▾
PRECAUTIONS: Do not use for intravenous injection unless the osmolar concentration of additives totals at least 112 mOsmol/liter (two-fifths of the normal osmolarity of the extracellular fluid ̶ 280 mOsmol/liter). Do not administer unless solution is clear and container is undamaged. Discard unused portion.
Pregnancy Category C 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 The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. This product contains no more than 25 mcg/L of aluminum.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Sterile Water 1,000 mL Bag Label free flex ® 1,000 mL Sterile Water for Injection, USP Do not give intravenously. For drug diluent use only. For intravenous use. Rx only red
Medicaid utilization & spend
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |