Sterile Water 1 mL/mL Injection, Solution
Other active recalls for Water (different manufacturers) — 3 · tap to view
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 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?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 | $0.3186 | $3,823.20 / 12000 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?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sterile Water 1 mL/mL 00517-3020-25 | American | 25 vials | $0.066 | — | FDA listed | — |
| Sterile Water 1 mL/mL 00517-3010-25 | American | 25 vials | $0.308 | — | Availability likely | — |
| Sterile Water 1 mL/mL 00264-7385-50 | B. | 2000 ml | — | AP | FDA listed | — |
| Sterile Diluent for Treprostinil 1 mL/mL 43598-0126-11 | Dr.Reddy's | 1 vial | — | AP | FDA listed | — |
| Sterile Diluent for Remodulin 1 mL/mL 66302-0150-50 | United | 1 vial | — | — | FDA listed | — |
| Sterile Water 1 mL/mLthis 00990-7118-07 | ICU | 2000 ml | — | AP | FDA listed | — |
| Sterile Water 1 mL/mL 84549-0850-10 | ProPharma | 500 ml | — | AP | FDA listed | — |
| Sterile Water 1 mL/mL 00264-7850-00 | B. | 1000 ml | — | AP | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Where does this data come from?
🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00990-7118-07 You're viewing this | 6 BAG in 1 CASE (0990-7118-07) / 2000 mL in 1 BAG | 2019-06-01 | Active |
🧭 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 |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Does this product have a billing J-code?
Where does this data come from?
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
Pharmacy Bulk Package — Not for Direct Infusion. FOR USE ONLY WITH AUTOMATED COMPOUNDING DEVICES.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Sterile Water for Injection, USP in the Pharmacy Bulk Package is indicated for use with automated compounding devices for preparing intravenous admixtures in the pharmacy.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Sterile Water for Injection, USP in the 2000 mL flexible Pharmacy Bulk Package is designed for use with automated compounding devices for preparing intravenous admixtures. Dosages will be in accordance with the recommendation of the prescribing physician. Sterile Water for Injection, USP is not intended for direct infusion.
Admixtures should be made by or under the direction of a pharmacist using strict aseptic technique under a laminar flow hood. Compounded admixtures may be stored under refrigeration for up to 24 hours. Administration of admixtures should be completed within 24 hours after removal from refrigeration.
Drug Interactions The Pharmacy Bulk Package is intended only for use in the preparation of sterile, intravenous admixtures using automated compounding devices. Additives may be incompatible with the fluid withdrawn from this container. Consult with pharmacist, if available.
When compounding admixtures, 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 container permits. See PRECAUTIONS.
Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
Recommended Directions for Use of the Pharmacy Bulk Package Use Aseptic Technique 1. During use, container must be stored, and all manipulations performed, in an appropriate laminar flow hood. 2.
Remove cover from outlet port at bottom of container. 3. Insert piercing pin of transfer set and suspend unit in a laminar flow hood.
Insertion of a piercing pin into the outlet port should be performed only once in a Pharmacy Bulk Package solution. Once the outlet site has been entered, the withdrawal of container contents should be completed promptly in one continuous operation. Should this not be possible, a maximum time of 4 hours from transfer set pin or implement insertion is permitted to complete fluid transfer operations; i.e., discard container no later than 4 hours after initial closure puncture.
4. Sequentially dispense aliquots of Sterile Water for Injection, USP into I.V. containers using appropriate transfer set. During fluid transfer operations, the Pharmacy Bulk Package should be maintained under the storage conditions recommended in the labeling.
⛔ Contraindications ▾
CONTRAINDICATIONS NOT FOR DIRECT INFUSION. DO NOT USE FOR NON-AUTOMATED ADMIXTURE PREPARATIONS.
⚠️ Warnings ▾
WARNINGS FOR DILUTION ONLY. Do not heat over 66°C (150°F). This preparation is solute-free and its entry into the circulation undiluted will cause hemolysis .
Absorption of large amounts of Sterile Water for Injection, USP 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 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 Accidental contamination from careless technique may transmit infection. Should any adverse reaction occur, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination, if deemed necessary.
🧬 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 (1.0 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 2000 mL flexible Pharmacy Bulk Packages. NDC No. Product Container Size (mL) 0409-7118-07 Sterile Water for Injection, USP 2000 0990-7118-07 Sterile Water for Injection, USP 2000 ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code.
Both codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Patent 4,368,765 Revised: July, 2018 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA EN-4665
📋 Description ▾
DESCRIPTION Sterile Water for Injection, USP is a sterile, nonpyrogenic water for injection intended only for dilution purposes. The pH is 5.4 (5.0 to 7.0). The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program.
Sterile Water for Injection, USP contains no bacteriostat, antimicrobial agent or added buffer. Sterile Water for Injection, USP may be classified as a sterile diluent and pharmaceutical vehicle. Sterile Water for Injection, USP is chemically designated H 2 O.
The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained.
However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.