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Sterile Water 100 mL/100mL Irrigant — NDC 00264-7386-60 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 0264-7386-60 (Billing 00264-7386-60)

by B. Braun Medical Inc. · 4 CONTAINER in 1 CASE / 3000 mL in 1 CONTAINER

This is a package of Sterile Water 100 mL/100mL Irrigant from B. Braun Medical Inc., marketed since Sep 2013 and currently FDA-listed.

NDC 00264-7386-60
🏷️ FDA NDC (as labeled) 0264-7386-60 billing pads the labeler segment with a zero
This package
Contains3000 mL in 1 container Pack sizes2 compare ↓
Product page 00264-7386-50 Also comes in: 2000 ml 0264-7386-50
Rx only Brand On market Non-controlled ⇄ 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 0264-7386-60 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0264 labeler · 7386 product · 60 package
Package marketed since
Sep 13, 2013
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0264738660 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0264-7386-60
Product NDC 0264-7386
11-digit billing NDC 00264738660
NCPDP billing unit ML — per mL (volume)
RxCUI 150985
UNII 059QF0KO0R
Application # NDA016734
SPL Set ID d99f9133-e4d0-4dee-b611-dbc3f918b547
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-09-13
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 0264-7386-60 — 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 → 00264-7386-60. 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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 2000 ml
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00264-7386-50 0264-7386-50 Main listing 4 CONTAINER in 1 CASE / 2000 mL in 1 CONTAINER 2013-09-13 — Active
00264-7386-60 You're viewing this 4 CONTAINER in 1 CASE / 3000 mL in 1 CONTAINER 2013-09-13 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 4 container in 1 case / 3000 ml in 1 container.
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/100mLthis 00264-7386-60 B. 3000 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

🏛️
2013
On the market since
Sep 2013
📍
2026
Currently FDA-listed
13 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.

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

LabelerB. Braun Medical Inc.
Application holderB BRAUN MEDICAL INC
FDA applicationNDA016734 (NDA)
Labeler code00264
First marketedSep 2013
Product typeHuman Prescription Drug
Portfolio94 products on file

More NDCs from B. Braun Medical Inc. labeler code 00264

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. 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 ⚠️ Precautions 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 41 words ▾

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 80 words ▾

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 4 words ▾

CONTRAINDICATIONS Not for injection.

⚠️ Warnings 51 words ▾

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 4 words ▾

ADVERSE REACTIONS None known.

🆘 Overdosage 3 words ▾

OVERDOSAGE None known.

🧬 Clinical Pharmacology 75 words ▾

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 75 words ▾

HOW SUPPLIED Sterile Water for Irrigation USP is supplied sterile and nonpyrogenic in single-dose 2000 and 3000 mL flexible irrigation containers packaged 4 per case. NDC REF SIZE 0264-7386-50 R8005 2000 mL 0264-7386-60 R8006 3000 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.

📋 Description 134 words ▾

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 made from a multilayered film specifically developed for parenteral drugs.

It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert.

The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Not made with natural rubber latex, PVC or DEHP.

⚠️ Precautions 13 words ▾

PRECAUTIONS Use only if solution is clear and container and seal are intact.

📖 Instructions for Use 170 words ▾

Directions for Use of Plastic Container Not for injection. Not for use with pressurized irrigation systems. Aseptic technique is required.

Inspect irrigation bag: overwrap and primary bag. Do not use if overwrap has been damaged. Do not use unless solution is clear and closure is intact.

To open: Tear overwrap starting from the tear notches. (Figure 1) Prepare medication port by removal of aluminum foil. (Figure 2a) Puncture resealable medication port by using 19 – 22 gauge needle and inject additive(s).

(Figure 2b) Mix solution and medication thoroughly. (Figure 3a) Medication port must be swabbed with disinfection agent before re-puncturing. Check admixture visually for particulate matter.

(Figure 3b) Remove aluminum foil from outlet/set port at the bottom of container (Figure 4a) and attach administration set (Figure 4b): use non-vented infusion set or close air vent on a vented set. Refer to directions for use accompanying the administration set. Hang bag on IV Pole.

(Figure 5) Tear Notches. Overwrap Illustration. Tear Overwrap Illustration Illustration 2 Illustration 3 Illustration 4 Illustration 5

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

PRINCIPAL DISPLAY PANEL STERILE WATER FOR IRRIGATION, USP INDICATIONS: FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION REF R8005 NDC 0264-7386-50 LOT EXP. 2000 mL No antimicrobial agent or other substance has been added. pH: 5.7 (5.0-7.0) WARNINGS: HYPOTONIC AND HEMOLYTIC See Package Insert. Use only if solution is clear and container and seal are intact.

Sterile, nonpyrogenic. Single unit container. Discard unused portion.

Dosage: Irrigation. Use as directed by physician. Recommended Storage: Room temperature (25°C).

Avoid excessive heat. Protect from freezing. See Package Insert.

Not made with natural rubber latex, PVC or DEHP. Rx only Y38-000-063 LD-255-6 B. Braun Medical Inc.

Bethlehem, PA 18018-3524 USA 1-800-227-2862 S ET Sterile Water Irrigation 2L Container Label Recycle 7 Symbol set arrow illustration Sterile Water Irrigation 2L Container Label

PRINCIPAL DISPLAY PANEL STERILE WATER FOR IRRIGATION, USP INDICATIONS: FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION REF R8006 NDC 0264-7386-60 LOT EXP. 3000 mL No antimicrobial agent or other substance has been added. pH: 5.7 (5.0-7.0) WARNINGS: HYPOTONIC AND HEMOLYTIC See Package Insert. Use only if solution is clear and container and seal are intact.

Sterile, nonpyrogenic. Single unit container. Discard unused portion.

Dosage: Irrigation. Use as directed by physician. Recommended Storage: Room temperature (25°C).

Avoid excessive heat. Protect from freezing. See Package Insert.

Not made with natural rubber latex, PVC or DEHP. Rx only Y38-000-064 LD-256-6 B. Braun Medical Inc.

Bethlehem, PA 18018-3524 USA 1-800-227-2862 SET Sterile Water Irrigation 3L Container Label Recycle 7 Symbol set arrow illustration Sterile Water Irrigation 3L Container Label

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

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.
2000 ml00264-7386-50 77 Rx · $2,046
3000 ml this page00264-7386-60 No Medicaid data
Drug total (last 4 qtrs): 77 Rx · 94,459 units · $2,046 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 — the ingredient across all brands.

Top reported reactions

Hereditary Angioedema576
Nausea267
Fatigue265
Headache254
Weight Increased232
Pyrexia226
Weight Decreased221

Age at onset

Neonate14
Infant16
Child196
Adolescent145
Adult1,465
Elderly212

Reporter sex

0 reports

Serious outcomes

Life-threatening148
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 599 0
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.

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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 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 1 other package presentation of this same product, including 2000 ml (00264-7386-50). 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.
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.
← 00264-7385-50 · B. 00264-7387-50 · B. →
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.