Sterile Water 1 mL/mL Irrigant
by B. Braun Medical Inc. · 16 CONTAINER in 1 CASE (0264-2101-00) / 1000 mL in 1 CONTAINER
NDC 00264-2101-00
🏷️ FDA NDC (as labeled)
0264-2101-00
billing pads the labeler segment with a zero
This package
Contains1000 mL in 1 container
Medicaid pays$0.0131 / unit · 12 mo
Per package$0.21 / 16 containers · Medicaid
Pack sizes4 compare ↓
Rx only
Brand
On market
Non-controlled
⚠ On shortage
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Active FDA shortage. Sterile Water Irrigant is currently reported in shortage by the FDA. Available Shortage details →
⚠️
Other active recalls for Water (different manufacturers) — 3 · 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 · 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
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
FDA NDC (as labeled)
0264-2101-00
Product NDC
0264-2101
11-digit billing NDC
00264210100
NCPDP billing unit
ML — per mL (volume)
RxCUI
150985
UNII
059QF0KO0R
Application #
NDA016734
SPL Set ID
f4284eb6-e553-46d4-90d8-efc80a90a480
DEA schedule
Non-controlled
Marketing category
NDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
1970-09-10
Route
IRRIGATION
Dosage form
IRRIGANT
Substance
WATER
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
TE code (Orange Book)
AT · RLD · RS
Why two NDCs?
The FDA registers this code as 0264-2101-00 — 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 → 00264-2101-00. 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.
🏭 Manufacturer & labeler
LabelerB. Braun Medical Inc.
Application holderB BRAUN MEDICAL INC
FDA applicationNDA016734 (NDA)
Labeler code00264
First marketedSep 1970
Product typeHuman Prescription Drug
Portfolio94 products on file
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.
🩺 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?
Patient education
Supplement & herbal interactions
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.
💬 Questions about Water?
Ask a pharmacist →
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.
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.
💲 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 | $0.0131 | $0.21 / 16 containers |
| 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)0264-2101-00
11-digit billing NDC00264-2101-00
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
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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sterile Water 1 mL/mLthis 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/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
🏛️
1970
On the market since
Sep 1970
📍
2026
Currently FDA-listed
56 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.
🗺️ 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 00264-2101-00, 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 – Q4 2025 · 4 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
23.5K
Units reimbursed last 4 qtrs
43.1M
Gross reimbursed last 4 qtrs
$563K
Avg / prescription
$23.98
Avg / unit
$0.0131
Latest quarter Q4 2025
5.3KRx
Fee-for-service vs managed care ⓘ
Fee-for-service · 12,944 Rx Managed care · 10,530 Rx
State Medicaid map
Units reimbursed · per 100k residents
11.474,750
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
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.
Drug total (last 4 qtrs): 27,023 Rx · 48,339,772 units · $626,318 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Sterile Water (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 37%
Female · 62%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00264-2101-00 You're viewing this | 16 CONTAINER in 1 CASE (0264-2101-00) / 1000 mL in 1 CONTAINER | 1970-09-10 | Active |
| 00264-2101-10 | 16 CONTAINER in 1 CASE (0264-2101-10) / 500 mL in 1 CONTAINER | 1970-09-10 | Active |
| 00264-2101-50 | 8 CONTAINER in 1 CASE (0264-2101-50) / 2000 mL in 1 CONTAINER | 1970-09-10 | Discontinued by firm |
| 00264-2101-70 | 4 CONTAINER in 1 CASE (0264-2101-70) / 4000 mL in 1 CONTAINER | 1970-09-10 | Discontinued by firm |
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 00264-2101-00?
NDC 00264-2101-00 is listed by the FDA — 16 container in 1 case / 1000 ml in 1 container.
What NDC number is used to bill for this package of Sterile Water 1 mL/mL Irrigant?
Bill NDC 00264-2101-00 — the 11-digit billing format is 00264210100. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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 FDA registers it as 0264-2101-00, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00264-2101-00, written without dashes as 00264210100. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00264-2101-00, the first segment (00264) is the labeler code FDA assigned to B. Braun Medical Inc.; the middle segment (2101) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
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 B. Braun Medical Inc.. 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 3 other package presentations of this same product, including 500 ml (00264-2101-10), 2000 ml (00264-2101-50), 4000 ml (00264-2101-70). 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?
B. Braun Medical Inc. 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.
📄 Full prescribing information FDA SPL
The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⛔ Contraindications
⚠️ Warnings
🤒 Adverse Reactions
🆘 Overdosage
🧬 Clinical Pharmacology
📦 How Supplied / Storage and Handling
📋 Description
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Sterile Water for Irrigation USP is indicated for use as an irrigating fluid or pharmaceutic aid. Sterile Water may also be used as an adjunct in the preparation of non-intravenously administered nutrient mixtures (see DOSAGE AND ADMINISTRATION ).
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Irrigation Use as directed by physician. This drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Nutrient Mixtures Sterile Water for Irrigation USP may be used to prepare non-intravenously administered nutrient mixtures.
It contains no electrolytes or other added substances. Refer to preparation instructions of particular mixture to be used. The plastic container may be used for administration of non-intravenous nutrient mixture to the patient as appropriate.
⛔ Contraindications ▾
CONTRAINDICATIONS Not for injection.
⚠️ Warnings ▾
WARNINGS Sterile Water for Irrigation USP is hypotonic and will cause hemolysis, and is not recommended for use during surgical procedures. After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard unused portion of irrigating solution since it contains no preservative.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS None known.
🆘 Overdosage ▾
OVERDOSAGE None known.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Sterile Water for Irrigation USP is utilized for a variety of clinical indications. Because of its low refractive index (1.3325), water provides excellent visibility during endoscopic urological procedures. It is also utilized as a pharmaceutic aid, as well as in the preparation of enteral nutrient products.
Water is hypotonic and will cause hemolysis and will be readily absorbed by the tissues during surgical procedures; therefore, its use under such conditions is not recommended.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Sterile Water for Irrigation USP is supplied sterile and nonpyrogenic in plastic irrigating containers. The 1000 mL and 500 mL containers are packaged 16 per case. NDC Cat.
No. Size Sterile Water for Irrigation USP (Canada DIN 01963961) 0264-2101-00 R5000-01 1000 mL 0264-2101-10 R5001-01 500 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.
Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).
📋 Description ▾
DESCRIPTION Sterile Water for Irrigation USP is a sterile, hypotonic, nonpyrogenic irrigating fluid or pharmaceutic aid (solvent) entirely composed of Sterile Water for Injection USP. It is prepared by distillation and contains no antimicrobial or bacteriostatic agents or added buffers. The pH is 5.7 (5.0–7.0) The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs.
The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures.
The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.
Not made with natural rubber Latex, PVC or DEHP.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.