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Sterile Water 100 mL/100mL Irrigant — NDC 00338-0004-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sterile Water 100 mL/100mL Irrigant — NDC 0338-0004-03 (Billing 00338-0004-03)

by Baxter Healthcare Corporation · 18 BOTTLE, PLASTIC in 1 CARTON / 500 mL in 1 BOTTLE, PLASTIC

This is a package of Sterile Water 100 mL/100mL Irrigant from Baxter Healthcare Corporation, marketed since Dec 1974 and currently FDA-listed.

NDC 00338-0004-03
🏷️ FDA NDC (as labeled) 0338-0004-03 billing pads the labeler segment with a zero
This package
Contains500 mL in 1 bottle, plastic Medicaid pays$0.0356 / unit · 12 mo Per package$0.64 / 18 bottles · Medicaid Pack sizes3 compare ↓
Product page 00338-0004-04 Also comes in: 12 bottles 0338-0004-04 24 bottles 0338-0004-02
Rx only Brand On market Non-controlled ⚠ On shortage ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0338-0004-03 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0338 labeler · 0004 product · 03 package
Package marketed since
Dec 31, 1974
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0338000403 4
Medicaid fills, this package
6,113 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Active FDA shortage. Sterile Water Irrigant is currently reported in shortage by the FDA (Other). Limited Availability Shortage details →
🚨
Active recall for this product.
Class II · Dec 22, 2025 — Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution (Baxter Healthcare Corporation) · FDA recall D-0296-2026
Lots / codes: Lot #: G171359, expiry: 05/31/2027 · reported Feb 4, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Water (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 2, 2026 — Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. (B BRAUN MEDICAL INC) · FDA recall D-0495-2026
Class II · Aug 26, 2025 — Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. (B BRAUN MEDICAL INC) · FDA recall D-0652-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0338-0004-03
Product NDC 0338-0004
11-digit billing NDC 00338000403
NCPDP billing unit ML — per mL (volume)
RxCUI 150985
UNII 059QF0KO0R
Application # NDA017428
SPL Set ID ef3e79c5-3f58-4b36-a296-64b7d9a651c1
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1974-12-31
Route IRRIGATION
Dosage form IRRIGANT
Substance WATER
TE code (Orange Book) AT · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 99750005002000
GPI class Sterile Water for Irrigation
GCN Seq No 009825
GCN 45340
HICL code 004283
Ingredient (HICL) Water For Irrigation,Sterile
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W8
Therapeutic class — intermediate (HIC2) Antiseptics
HIC3 code W8F
Therapeutic class — specific (HIC3) Irrigants
AHFS code 40:36.00.00
AHFS class Irrigating Solutions
FDB label name STERILE WATER FOR IRRIGATION
FDB brand name Water
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009825
  • GCN: 45340
  • GPI-14 (Medi-Span): 99750005002000
  • HICL (First Databank): 004283
  • AHFS class code: 40:36.00.00
  • RxCUI (RxNorm): 150985
Why two NDCs? The FDA registers this code as 0338-0004-03 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00338-0004-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name STERILE WATER FOR IRRIGATION Ingredient Water For Irrigation,Sterile
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Water guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.0356 $0.64 / 18 bottles
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?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)0338-0004-03
11-digit billing NDC00338-0004-03
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeA4217
DescriptorSTERILE WATER/SALINE, 500 ML
Billing units / pkg0 units
How the units are derivedThis package is 500 ML; the HCPCS unit is 500 ML, so one package = 0 billing units.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00338-0004-02 0338-0004-02 24 BOTTLE, PLASTIC in 1 CARTON / 250 mL in 1 BOTTLE, PLASTIC 1974-12-31 — Active
00338-0004-03 You're viewing this 18 BOTTLE, PLASTIC in 1 CARTON / 500 mL in 1 BOTTLE, PLASTIC 1974-12-31 — Active
00338-0004-04 0338-0004-04 Main listing 12 BOTTLE, PLASTIC in 1 CARTON / 1000 mL in 1 BOTTLE, PLASTIC 1974-12-31 — Active

This pack accounts for about 13% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 18 bottle, plastic in 1 carton / 500 ml in 1 bottle, plastic.
What NDC number is used to bill for this package of Sterile Water 100 mL/100mL Irrigant?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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/100mLthis 00338-0004-03 Baxter 18 bottles — AT FDA listed —
Sterile Water 1 mL/mL 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 —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1974
On the market since
Dec 1974
📍
2026
Currently FDA-listed
52 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured 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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerBaxter Healthcare Corporation
Application holderBAXTER HEALTHCARE CORP
FDA applicationNDA017428 (NDA)
Labeler code00338
First marketedDec 1974
Product typeHuman Prescription Drug
Portfolio283 products on file

More NDCs from Baxter Healthcare Corporation labeler code 00338

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 29 words ▾

1 INDICATIONS AND USAGE Sterile Water for Irrigation is indicated for use as an irrigant. Sterile Water for Irrigation is indicated for use as an irrigant. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • For Irrigation only. Not for injection or infusion by usual parenteral routes. ( 2.1 , 5.1 ) • The volume and/or rate of irrigation depend on the type of the procedure and the capacity or the surface area of the structure to be irrigated. ( 2.2 ) • For preparation and administration instructions see the full prescribing information. ( 2.1 , 2.3 )

2.1Important Administration Instructions • For irrigation only. Not for intravenous injection. • Sterile Water for Irrigation is hypotonic with an osmolarity of zero mOsmol/L. It is intended for use as an irrigation fluid and not for intravenous administration or administration by other, parenteral routes (e.g., subcutaneous or intramuscular) [see Warnings and Precautions (5.1) ]. • Sterile Water for Irrigation is not potable water and is not intended for oral administration. • Sterile Water for Irrigation that has been warmed must not be returned to storage.

2.2Recommended Dosage The volume and/or rate of irrigation depend on the type of the procedure and the capacity or the surface area of the structure to be irrigated.

2.3Preparation and Administration Instructions For single-dose only. Sterile Water for Irrigation is available in a flexible plastic container and a plastic pour bottle. Use the contents of the opened container immediately to minimize the potential for bacterial growth and pyrogen formation.

Discard the unused contents of opened containers, as Sterile Water for Irrigation contains no antimicrobial preservative. Adding Medications to Either the Flexible Plastic Container or the Plastic Pour Bottle • Use aseptic technique when making additions to Sterile Water for Irrigation. • Additives may be incompatible with Sterile Water for Irrigation. • The compatibility of additives with Sterile Water for Irrigation must be assessed. Before introducing additives, check for a possible color change and/or the appearance of precipitates, insoluble complexes, or crystals. • Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Sterile Water for Irrigation is appropriate. • Additives known or determined to be incompatible should not be used. • Mix thoroughly after additives have been introduced. • Use immediately.

Administration Instructions for Irrigation by Gravity Using the Flexible Plastic Container 1. Use aseptic technique. 2.

Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired.

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.

Check for minute leaks by squeezing the container firmly. If leaks are found, discard solution as sterility may be impaired. 3.

Suspend container using hanger hole. 4. Remove plastic protector from outlet port at bottom of container.

5. Attach irrigation set. Refer to complete directions accompanying set.

Warming If desired, warm the flexible plastic container in overwrap to near body temperature in a water bath or fluid warmer heated to not more than 45°C. Microwave heating of irrigation fluids is not recommended. Administration Using the Plastic Pour Bottle 1.

Inspect Sterile Water for Irrigation visually for particulate matter and discoloration prior to use. Discard if the fluid is not clear or the seal is broken. 2.

Use aseptic technique 3. Remove the plastic shrink band by tearing along the perforation line and unscrew the bottle cap. 4.

Prevent contact of the fluid with the external surface of the container (including the thread for the bottle cap of the plastic pour bottle). Warming If desired, warm the plastic pour bottle in a fluid warmer to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming.

Microwave… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 78 words ▾

3 DOSAGE FORMS AND STRENGTHS Irrigation: • 250, 500, 1000, and 1500 mL sterile water for irrigation in a single-dose plastic pour bottle • 1000, 2000 and 3000 mL sterile water for irrigation in a single-dose flexible plastic container • 250, 500, 1000, and 1500 mL sterile water for irrigation in a single-dose plastic pour bottle. ( 3 ) • 1000, 2000 and 3000 mL sterile water for irrigation in a single-dose flexible plastic container. ( 3 )

⛔ Contraindications 8 words ▾

4 CONTRAINDICATIONS None. • None. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Hypotonicity : Administration by parenteral routes can result in serious adverse reactions. For irrigation use only. ( 5.1 ) • Excessive Water Absorption : May result in hyponatremia, hypoosmolality and fluid overload.

Monitor patients for absorption of clinically relevant amounts of fluid during and after the procedure. Additional monitoring is recommended for patients at increased risk of developing complications of fluid overload syndrome (e.g., patients with renal or cardiac impairment) or hyponatremic encephalopathy (e.g., pediatric patients; women, in particular premenopausal women; patients with hypoxemia; and patients with central nervous system disease). Avoid use in procedures that require longer irrigation times or an irrigation fluid pressure that promotes absorption.

( 5.2 , 8.4 ) • Use with Electrosurgery/Cautery : Ensure compatibility with equipment used with electrosurgery or cautery. ( 5.2 )

5.1Hypotonicity Sterile Water for Irrigation is hypotonic with an osmolarity of zero mOsmol/L. It is intended for use as irrigation fluid and not for intravenous administration or administration by other, usual parenteral routes, such as intravascular administration in general, subcutaneous administration, or intramuscular administration. Serious adverse reactions, including cerebral or pulmonary edema, massive hemolysis, and acute renal failure can result from the hypotonicity of Sterile Water for Irrigation [see Warnings and Precautions (5.2) ].

5.2Excessive Water Absorption Due to the hypotonicity, absorption of Sterile Water for Irrigation can result in serious adverse reactions of hyponatremia, hypoosmolality and fluid overload, resulting in fatality or permanent morbidity. Complications include cerebral edema, encephalopathy, pulmonary edema, massive hemolysis, rhabdomyolysis, renal failure, and hyperkalemia [see Adverse Reactions (6) ]. In addition, excessive volume or pressure of the irrigation fluid may also cause undue distension of body cavities and may cause tissue disruption (e.g., tears or perforation).

These complications can manifest after irrigation has ended and immediate intervention may be required. Monitor patients closely for absorption of clinically relevant amounts of fluid during and for an appropriate period after the procedure. If absorption occurs, discontinue Sterile Water for Irrigation.

Additional close monitoring during and/or after the procedure is recommended for patients at increased risk for developing complications related to hypotonicity, such as: • fluid overload syndrome, including patients with severe renal impairment, impaired cardiac function, or other clinical conditions associated with edematous states. • hyponatremic encephalopathy, including pediatric patients; women, in particular premenopausal women; patients with hypoxemia; and patients with underlying central nervous system disease.

Avoid use of Sterile Water for Irrigation in patients with wounds where significant absorption may occur, such as procedures that require irrigation over a longer period of time or an irrigation fluid pressure that promotes absorption (e.g., transurethral resection of prostate). Sterile Water for Irrigation should only be used by clinicians familiar with the treatment of possible complications.

5.3Use with Electrosurgery/Cautery In contrast to other irrigation fluids containing electrolytes, Sterile Water for Irrigation is non-conductive. Therefore, when choosing the distension solution/fluid used with electrosurgery or cautery, ensure compatibility with the equipment.

🤒 Adverse Reactions 207 words ▾

6 ADVERSE REACTIONS The following adverse reactions have been identified during post approval use of Sterile Water for Irrigation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Metabolism and Nutrition disorders : Hyponatremia, fluid overload, fluid absorption, electrolyte imbalance Nervous System Disorders : Cerebral edema General Disorders and Administration Site Conditions : Burning sensation (with irrigation of eyes and skin wounds) Musculoskeletal and Connective Tissue Disorders : Rhabdomyolysis (myoglobinuria) Renal and Urinary Disorders : Renal failure Other Adverse reactions which may occur in association with absorption of water for irrigation include: Blood and Lymphatic System Disorders : Hemolysis (hemoglobinemia, hemoglobinuria) Metabolism and Nutrition Disorders : Hypervolemia, hypoosmolality, hyperkalemia, acid/base balance disorder Nervous System Disorders : Encephalopathy (seizure, loss of vision, lethargy, disorientation, irritability, vomiting, nausea, headache) Cardiac Disorders : Cardiac arrest, cardiac failure, bradycardia, electrocardiogram abnormal Vascular Disorders : Hypertension, postoperative hypotension Respiratory, Thoracic and Mediastinal Disorders: Respiratory arrest, respiratory failure, pulmonary edema Most common adverse reactions are: hyponatremia, fluid overload, fluid absorption, electrolyte imbalance.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Appropriate administration of Sterile Water for Irrigation is not expected to cause adverse developmental outcomes. There are no available data on Sterile Water for Irrigation use in pregnant women to determine a drug-associated risk of adverse developmental outcomes. Animal reproduction studies have not been conducted with Sterile Water for Irrigation.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively.

8.2Lactation Risk Summary Appropriate administration of Sterile Water for Irrigation is not expected to cause harm to a breastfed infant. There are no data on the presence of Sterile Water for Irrigation in either human or animal milk, the effects on the breastfed infant or the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of Sterile Water for Irrigation to a breastfed infant; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Sterile Water for Irrigation and any potential adverse effects on the breastfed infant from Sterile Water for Irrigation or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Pediatric patients are at higher risk compared to adults for developing encephalopathy as a complication of hyponatremia, if there is excessive absorption of Sterile Water for Irrigation [see Warnings and Precautions (5.2) ].

8.5Geriatric Use Sterile Water for Irrigation should be used cautiously in older patients. Geriatric patients are more likely to have decreased cardiac, renal, or hepatic function, and other diseases or concomitant drug therapy.

🤰 Pregnancy 96 words ▾

8.1Pregnancy Risk Summary Appropriate administration of Sterile Water for Irrigation is not expected to cause adverse developmental outcomes. There are no available data on Sterile Water for Irrigation use in pregnant women to determine a drug-associated risk of adverse developmental outcomes. Animal reproduction studies have not been conducted with Sterile Water for Irrigation.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively.

🧒 Pediatric Use 46 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Pediatric patients are at higher risk compared to adults for developing encephalopathy as a complication of hyponatremia, if there is excessive absorption of Sterile Water for Irrigation [see Warnings and Precautions (5.2) ].

🧓 Geriatric Use 34 words ▾

8.5Geriatric Use Sterile Water for Irrigation should be used cautiously in older patients. Geriatric patients are more likely to have decreased cardiac, renal, or hepatic function, and other diseases or concomitant drug therapy.

🆘 Overdosage 56 words ▾

10 OVERDOSAGE Excessive rate, volume, pressure or duration of irrigation with hypotonic fluid can result in excessive fluid absorption and permanent morbidity or death as a result of hyponatremia, hypoosmolality and/or fluid overload. In the event of clinically relevant absorption of Sterile Water for Irrigation, immediate intervention may be required [see Warnings and Precautions (5.2) ].

📦 How Supplied / Storage and Handling 85 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Sterile Water for Irrigation is supplied in single-dose plastic pour bottles and flexible plastic containers as follows: Container Product Codes Fill Volume (mL) NDC Plastic Pour Bottle 2F7112 250 0338-0004-02 2F7113 500 0338-0004-03 2F7114 1000 0338-0004-04 2F7115 1500 0338-0004-05 Flexible Plastic Container 2B7114 1000 0338-0003-44 2B7116 2000 0338-0003-46 2B7117 3000 0338-0003-47 Storage Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Store at room temperature (25°C): brief exposure up to 40°C does not adversely affect the product.

📋 Description 137 words ▾

11 DESCRIPTION Sterile Water for Irrigation contains water that is sterilized and packaged for use as an irrigant. No antimicrobial agent or other substance has been added. The pH is 5.5 (5.0 to 7.0).

Sterile Water for Irrigation is hypotonic with an osmolarity of zero mOsmol/L. The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the fluid significantly.

Water 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. The plastic pour bottle is fabricated from specially formulated polyolefin. The polyolefin is a copolymer of ethylene and propylene.

The container requires no vapor barrier.

💬 Information for Patients 38 words ▾

17 PATIENT COUNSELING INFORMATION Inform patients, caregivers, or home healthcare providers of the following risks of Sterile Water for Irrigation: • Hypotonicity [see Warnings and Precautions (5.1) ] • Excessive Water Absorption [see Warnings and Precautions (5.2) ]

📄 Package Label / Principal Display Panel ~1 min read ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label 2F7114 NDC 0338-0004-04 1000 mL Baxter Logo Not for Injection For Irrigation Only Sterile Water for Irrigation USP Prepared by distillation. No antimicrobial agent or other substance has been added. pH 5.5 (5.0 to 7.0). Osmolarity 0 mOsmol/L (calc.).

Sterile, nonpyrogenic. Pour Bottle. Warning: This solution is not isotonic and is hemolytic.

Dosage and Administration: As directed by a physician. Cautions: Warm in oven to not more than 50ºC for a maximum of 60 days. Discard after 60 days of warming.

Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only.

Recommended storage: Room temperature (25ºC). Avoid excessive heat. PL 325 Plastic Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in USA LOT EXP FPO (91)0709000246 Bar Code 07-09-00-0246 Bar Code Position Only* 303380004041 LOT EXP 2000 mL NOT FOR INJECTION 2B7116 NDC 0338-0003-46 STERILE WATER For Irrigation USP For irrigation only Prepared by distillation No antimicrobial agent or other substance has been added pH 5.5 (5.0 TO 7.0).

Osmolarity 0 mOsmol/L (calc) Sterile Nonpyrogenic Single dose container Do not use unless fluid is clear Discard unused portion Cautions This fluid is not isotonic and is hemolytic Squeeze and inspect inner bag which maintains product sterility Discard if leaks are found Rx Only Store unit in moisture barrier overwrap at room temperature (25ºC) until Ready to use Avoid excessive heat See insert Sterile Water H 2 0 For Irrigation USP UROMATIC container Baxter Logo Baxter Healthcare Corporation Deerfield IL 60015 USA Made in USA PL 146 Plastic Baxter UROMATIC and PL 146 are trademarks of Baxter International Inc For product information 1-800-933-0303 1800 1600 1400 1200 1000 800 600 400 200 Representative bottle label 0338-0004-04.jpg Representative Container Label 0338-0003-46

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
6.1K
Units reimbursed last 4 qtrs
6M
Gross reimbursed last 4 qtrs
$213K
Avg / prescription
$34.84
Avg / unit
$0.0356
Latest quarter Q1 2026
1.5KRx
Fee-for-service vs managed care ⓘ
41% FFS 59% MCO
Fee-for-service · 2,480 Rx Managed care · 3,633 Rx
State Medicaid map
Alaska: 12,243 units · 1,670 per 100k residents AK Maine: no data reported ME Washington: 82,935 units · 1,062 per 100k residents WA Idaho: no data reported ID Montana: 604 units · 53.4 per 100k residents MT North Dakota: no data reported ND Minnesota: 93,765 units · 1,634 per 100k residents MN Wisconsin: 231,183 units · 3,912 per 100k residents WI Michigan: no data reported MI New York: 637,084 units · 3,255 per 100k residents NY Vermont: 10,572 units · 1,634 per 100k residents VT New Hampshire: 12,808 units · 914 per 100k residents NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 6,000 units · 87.4 per 100k residents IN Ohio: 351,561 units · 2,983 per 100k residents OH Pennsylvania: 1,563 units · 12.1 per 100k residents PA New Jersey: 7,259 units · 78.1 per 100k residents NJ Massachusetts: 15 units · 0.2 per 100k residents MA California: 150,896 units · 387 per 100k residents CA Utah: no data reported UT Colorado: 47,615 units · 810 per 100k residents CO Nebraska: no data reported NE Missouri: 4,056 units · 65.5 per 100k residents MO Kentucky: 158,954 units · 3,512 per 100k residents KY West Virginia: no data reported WV Virginia: 100,240 units · 1,150 per 100k residents VA Maryland: 63,107 units · 1,021 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 105,632 units · 3,593 per 100k residents KS Arkansas: no data reported AR Tennessee: 1,897 units · 26.6 per 100k residents TN North Carolina: 175,333 units · 1,618 per 100k residents NC South Carolina: 17,539 units · 326 per 100k residents SC Delaware: no data reported DE Oklahoma: 115,500 units · 2,850 per 100k residents OK Louisiana: no data reported LA Mississippi: 3,232,023 units · 109,933 per 100k residents MS Alabama: no data reported AL Georgia: 1,960 units · 17.8 per 100k residents GA D.C.: 3,715 units · 547 per 100k residents DC Hawaii: no data reported HI Texas: no data reported TX Florida: 351,772 units · 1,556 per 100k residents FL
Units reimbursed · per 100k residents
0.2109,933
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Mississippi 109,933 /100k
2 Wisconsin 3,912 /100k
3 Kansas 3,593 /100k
4 Kentucky 3,512 /100k
5 New York 3,255 /100k
6 Ohio 2,983 /100k
7 Oklahoma 2,850 /100k
8 Alaska 1,670 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
12 bottles00338-0004-04 39,228 Rx · $1,381,036
18 bottles this page00338-0004-03 6,113 Rx · $212,984
24 bottles00338-0004-02 3,067 Rx · $220,387
Drug total (last 4 qtrs): 48,408 Rx · 52,830,721 units · $1,814,407 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

About this NDC listing & data coverage

Finished prescription product
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
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Baxter Healthcare Corporation. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 12 bottles (00338-0004-04), 24 bottles (00338-0004-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Baxter Healthcare Corporation is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code A4217 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00338-0003-44 · Baxter 00338-0006-20 · Baxter →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.