Sterile Water 1 mL/mL Irrigant
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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.0328 | $0.39 / 12 bags |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · A4217 | No ASP payment limit on file for A4217 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 00264-2101-00 | B. | 1000 ml | — | AT | FDA listed | — |
| Sterile Water 100 mL/100mL 00264-7386-50 | B. | 2000 ml | — | AT | FDA listed | — |
| Sterile Water 100 mL/100mL 00338-0003-44 | Baxter | 1000 ml | — | AT | FDA listed | — |
| Sterile Water 100 mL/100mL 00338-0004-02 | Baxter | 24 bottles | — | AT | FDA listed | — |
| Sterile Water 1 mL/mLthis 00990-7973-05 | ICU | 12 pouches | — | AT | FDA listed | — |
| Sterile Water 1 mL/mL 17271-0802-07 | Becton | 1000 ml | — | AT | FDA listed | — |
| Sterile Water 1 mL/mL 65219-0495-10 | Fresenius | 1000 ml | — | AT | FDA listed | — |
| Sterile Water 1 mL/mL 65219-0497-20 | Fresenius | 2000 ml | — | AT | FDA listed | — |
| Sterile Water 1 mL/mL 65219-0499-30 | Fresenius | 3000 ml | — | AT | 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
💊 Medicaid utilization by pack size
🔬 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 |
|---|---|---|---|
| 00990-7973-05 You're viewing this | 12 POUCH in 1 CASE (0990-7973-05) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG | 2019-09-01 | Active |
| 00990-7973-07 | 6 POUCH in 1 CASE (0990-7973-07) / 1 BAG in 1 POUCH / 2000 mL in 1 BAG | 2019-10-01 | Active |
| 00990-7973-08 | 4 POUCH in 1 CASE (0990-7973-08) / 1 BAG in 1 POUCH / 3000 mL in 1 BAG | 2019-08-01 | Active |
In Medicaid, this is the most-dispensed pack of this product — about 87% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00990-7973-05?
What NDC number is used to bill for this package of Sterile Water 1 mL/mL Irrigant?
🧭 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?
Does this product come in other package sizes?
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
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Sterile Water for Irrigation, USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of sterile, nonpyrogenic, solute-free water.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a diluent or vehicle for drugs, the manufacturer's recommendations should be followed. 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 container permits.
(See PRECAUTIONS .)
⛔ Contraindications ▾
CONTRAINDICATIONS NOT FOR INJECTION BY USUAL PARENTERAL ROUTES.
⚠️ Warnings ▾
WARNINGS FOR IRRIGATION ONLY. This preparation is solute-free and its entry into the circulation will cause hemolysis. Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction.
Irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes, thus, Sterile Water for Irrigation, USP must be regarded as a systemic drug. Absorption of large amounts of Sterile Water for Irrigation, USP with or without 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. Do not heat container over 66°C (150°F).
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes are completely avoidable when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distention or disruption of tissues.
Accidental contamination from careless technique may transmit infection. Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination, if deemed necessary.
🤰 Pregnancy ▾
Pregnancy: Teratogenic Effects. Pregnancy Category C. Animal reproduction studies have not been conducted with Sterile Water for Irrigation, USP. It is also not known whether Sterile Water for Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile Water for Irrigation, USP should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
🆘 Overdosage ▾
OVERDOSAGE In the event of overhydration or solute overload (if solutes have been added to the irrigation), re-evaluate the patient and institute appropriate corrective measures. (See WARNINGS , PRECAUTIONS and ADVERSE REACTIONS .)
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Sterile Water for Irrigation, USP exerts a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations. 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 NDC No. Product Container Size (mL) Container Type 0409-6139-22 Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 0990-6139-22 Sterile Water for Irrigation USP 250 Semi-Rigid Irrigation 0409-6139-03 0990-6139-03 Sterile Water for Irrigation USP 500 Semi-Rigid Irrigation 0409-7139-09 0990-7139-09 Sterile Water for Irrigation USP 1000 Semi-Rigid Irrigation 0409-7139-36 0990-7139-36 Sterile Water for Irrigation USP 1500 Semi-Rigid Irrigation 0409-7973-05 Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 0990-7973-05 Sterile Water for Irrigation USP 1000 Flexible Irrigation 0409-7973-07 0990-7973-07 Sterile Water for Irrigation USP 2000 Flexible Irrigation 0409-7973-08 0990-7973-08 Sterile Water for Irrigation USP 3000 Flexible Irrigation ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code.
Both NDC 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. Revised: July, 2018 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA EN-4662
📋 Description ▾
DESCRIPTION Sterile Water for Irrigation, USP is a sterile, distilled, nonpyrogenic water for injection intended only for sterile irrigation, washing, rinsing and dilution purposes. pH 5.5 (5.0 to 7.0). Sterile Water for Irrigation, USP contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded.
Sterile Water for Irrigation, USP may be classified as a sterile irrigant, wash, rinse, diluent and pharmaceutical vehicle. Water for Irrigation, 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. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene.
The container requires no vapor barrier to maintain the proper drug concentration. 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 in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses.
It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.