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Sterile Water 1 mL/mL Injection — NDC 00264-7385-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sterile Water 1 mL/mL Injection — NDC 0264-7385-60 (Billing 00264-7385-60)

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

This is a package of Sterile Water 1 mL/mL Injection from B. Braun Medical Inc., marketed since Sep 2014 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00264-7385-60
🏷️ FDA NDC (as labeled) 0264-7385-60 billing pads the labeler segment with a zero
This package
Contains3000 mL in 1 container Medicaid pays$0.1174 / unit · 12 mo Per package$0.47 / 4 containers · Medicaid Pack sizes2 compare ↓
Main listing for product 0264-7385 · Also comes in: 2000 ml 0264-7385-50
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 0264-7385-60 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0264 labeler · 7385 product · 60 package
Package marketed since
Sep 4, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0264738560 2
Medicaid fills, this package
6,516 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
🚨
Active recall for this product.
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
Lots / codes: Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028. · reported Apr 29, 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
Lots / codes: Lot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027 · reported Sep 24, 2025
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) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
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
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) 0264-7385-60
Product NDC 0264-7385
11-digit billing NDC 00264738560
NCPDP billing unit ML — per mL (volume)
UNII 059QF0KO0R
Application # NDA019633
SPL Set ID 8924e52e-8622-4ed6-a061-1908183e0a18
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-09-04
Route INTRAVENOUS
Dosage form INJECTION
Substance WATER
TE code (Orange Book) AP · RLD · RS

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

GPI-14 98401010002000
GPI class Sterile Water for Injection
GCN Seq No 001166
GCN 02729
HICL code 000517
Ingredient (HICL) Water For Injection,Sterile
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C0
Therapeutic class — intermediate (HIC2) Affect Fluid/Acid-Base Balance/Metabolic Systems
HIC3 code C0B
Therapeutic class — specific (HIC3) Water
AHFS code 96:00.00.00
AHFS class Pharmaceutical Aids
FDB label name STERILE WATER FOR INJECTION
FDB brand name Water
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001166
  • GCN: 02729
  • GPI-14 (Medi-Span): 98401010002000
  • HICL (First Databank): 000517
  • AHFS class code: 96:00.00.00
Why two NDCs? The FDA registers this code as 0264-7385-60 — 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 → 00264-7385-60. 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 INJECTION Ingredient Water For Injection,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 $0.1174 $0.47 / 4 containers
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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
00264-7385-50 0264-7385-50 4 CONTAINER in 1 CASE / 2000 mL in 1 CONTAINER 2014-09-04 — Active
00264-7385-60 You're viewing this Main listing 4 CONTAINER in 1 CASE / 3000 mL in 1 CONTAINER 2014-09-04 — Active

In Medicaid, this is the most-dispensed pack of this product — about 67% of fills over the last four reported quarters. See all packs ↓

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 1 mL/mL Injection?
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 00517-3020-25 American 25 vials $0.066 — FDA listed —
Sterile Water 1 mL/mL 00517-3010-25 American 25 vials $0.315 — Availability likely —
Sterile Water 1 mL/mLthis 00264-7385-60 B. 3000 ml — AP FDA listed —
Sterile Diluent for Treprostinil 1 mL/mL 43598-0126-11 Dr.Reddy's 1 vial — AP FDA listed —
Sterile Diluent for Remodulin 1 mL/mL 66302-0150-50 United 1 vial — — FDA listed —
Sterile Water 1 mL/mL 00990-7118-07 ICU 2000 ml — AP FDA listed —
Sterile Water 1 mL/mL 84549-0850-10 ProPharma 500 ml — AP FDA listed —
Sterile Water 1 mL/mL 00264-7850-00 B. 1000 ml — AP FDA listed —
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

🏛️
2014
On the market since
Sep 2014
📍
2026
Currently FDA-listed
12 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 applicationNDA019633 (NDA)
Labeler code00264
First marketedSep 2014
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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 38 words ▾

INDICATIONS AND USAGE Sterile Water for Injection USP is indicated for use in adults and pediatric patients as a diluent in the aseptic preparation of parenteral solutions or as a vehicle for drug administration after admixture or dilution.

⏱️ Dosage and Administration 134 words ▾

DOSAGE AND ADMINISTRATION This solution is for intravenous use only after admixture or dilution. Do not inject until made approximately isotonic by addition of appropriate solute. Following suitable admixture of prescribed drugs, the dosage is usually dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

See directions accompanying drugs. The dosage and administration of Sterile Water for Injection USP is dependent upon the recommended dosage and administration of the solute used. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Some additives may be incompatible. Consult with pharmacist. When performing admixture or dilution, use aseptic techniques.

Mix thoroughly. Do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

⛔ Contraindications 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings 162 words ▾

WARNINGS This solution is for compounding only, not for direct infusion. Hypotonic and hemolytic. Do not inject until made approximately isotonic by addition of an appropriate solute, due to the possibility of hemolysis.

The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. WARNING: This product contains aluminum that may be toxic.

Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.

Tissue loading may occur at even lower rates of administration.

🤒 Adverse Reactions 103 words ▾

ADVERSE REACTIONS Refer to the package insert of the solute used. Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. The physician should also be alert to the possibility of adverse reactions to drug additives.

Prescribing information for drug additives to be administered in this manner should be consulted. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

🤰 Pregnancy 12 words ▾

Usage in Pregnancy Refer to the package insert of the solute used.

🧒 Pediatric Use 16 words ▾

Pediatric Use Refer to the package insert of the solute used. See WARNINGS section regarding aluminum.

🧓 Geriatric Use 16 words ▾

Geriatric Use Refer to the package insert of the solute used. See WARNINGS section regarding aluminum.

🆘 Overdosage 133 words ▾

OVERDOSAGE Overdosage (hypotonic expansion) is a function of an increase in fluid intake over fluid output, and occurs when the increase in the volume of body fluids is due to water alone. Overdosage may occur in patients who receive large quantities of electrolyte-free water to replace abnormal excessive fluid losses, in patients whose renal tolerance to water loads is exceeded, or in patients who retain water postoperatively in response to stress. Manifestations of water intoxication are behavioral changes (confusion, apathy, disorientation and attendant hyponatremia), central nervous system disturbances (weakness, muscle twitching, headaches, nausea, vomiting, convulsions) and weight gain.

Treatment consists of withholding fluids until excessive water is excreted. In severe hyponatremia it may be necessary to cautiously administer hypertonic saline to increase extracellular osmotic pressure and excretion of excess water by the kidneys.

🧬 Clinical Pharmacology 51 words ▾

CLINICAL PHARMACOLOGY Sterile Water for Injection USP is used as a diluent for other parenteral drugs. As such, Sterile Water for Injection USP contributes to the water for hydration when provided in parenteral drug and fluid therapy, after the introduction of suitable additives and/or mixture with suitable solutes to approximate isotonicity.

📦 How Supplied / Storage and Handling 72 words ▾

HOW SUPPLIED Sterile Water for Injection USP is supplied in 2000 and 3000 mL Pharmacy Bulk Package containers packaged 4 per case. NDC REF Size 0264-7385-50 S8505 2000 mL 0264-7385-60 S8506 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.

📦 Storage and Handling 39 words ▾

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 141 words ▾

DESCRIPTION Sterile Water for Injection USP is a clear, colorless, odorless liquid. It is sterile, hypotonic, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Sterile Water for Injection USP is a diluent suitable for intravascular injection after first having been made approximately isotonic by the addition of suitable solute. pH: 5.5 (5.0-7.0) Not made with natural rubber latex, PVC or DEHP.

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 use. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

⚠️ Precautions ~1 min read ▾

PRECAUTIONS General To minimize the risk of possible incompatibilities arising from the mixing of additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration and periodically during administration. Do not use plastic container in series connection. If administration of Sterile Water for Injection USP after admixture or dilution is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container. This solution is intended for intravenous administration after admixture or dilution using sterile equipment.

It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Use only if solution is clear and container and seals are intact. The drug product contains no more than 25 mcg/L of aluminum.

Carcinogenesis, Mutagenesis, Impairment of Fertility Refer to the package insert of the solute used. Usage in Pregnancy Refer to the package insert of the solute used. Nursing Mothers Refer to the package insert of the solute used.

Pediatric Use Refer to the package insert of the solute used. See WARNINGS section regarding aluminum. Geriatric Use Refer to the package insert of the solute used.

See WARNINGS section regarding aluminum.

🍼 Nursing Mothers 11 words ▾

Nursing Mothers Refer to the package insert of the solute used.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Refer to the package insert of the solute used.

📄 Patient Package Insert ~2 min read ▾

Directions for use of Plastic Container Warning: Hypotonic and hemolytic. Do not inject until made approximately isotonic by addition of appropriate solute. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration and final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration, whenever solution and container permit.

Use of a final filter is recommended during administration of all parenteral solutions where possible. Sterile Water for Injection USP in the Pharmacy Bulk Package is intended for use in the preparation of sterile, intravenous admixtures. Additives may be incompatible with the fluid withdrawn from this container.

Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available.

When compounding admixtures, use aseptic technique. Mix thoroughly. Do not store any unused portion of Sterile Water for Injection USP.

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

1. To open: Tear overwrap starting from the tear notches. (Figure 1) For Pharmacy Bulk Packages The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar air flow hood (or an equivalent clean air compounding area).

For compounding only. Do not use for direct infusion. Do not use/penetrate blocked port (see Figure 2, left upper corner).

Suspend container. Remove aluminum foil of set port at the bottom of container (see Figure 3). Attach suitable transfer device or compounding set (Figure 2).

Refer to complete directions accompanying device. Hang bag on suitable fixture (Figure 4). Once container closure has been penetrated, withdrawal of content should be completed within 4 hours.

Important Admixing Instructions The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion or, through a sterile transfer device, for the filling of empty sterile syringes. Additives may be incompatible with the fluid withdrawn from this container. Consult with pharmacist, if available.

When compounding admixtures, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. (See PRECAUTIONS, General ) .

Tear Notches, Overwrap illustration Figure 1 Bag hanger, Set Port (Green Ring), Blocked Port (Red Ring) Illustration Figure 2 Figure 3 Figure 4

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

PRINCIPAL DISPLAY PANEL - 2000 mL STERILE WATER FOR INJECTION USP WARNING: HYPOTONIC AND HEMOLYTIC. DO NOT INJECT UNTIL MADE APPROXIMATELY ISOTONIC BY ADDITION OF APPROPRIATE SOLUTE. REF S8505 NDC 0264-7385-50 LOT EXP.

2000 mL Pharmacy Bulk Package Not For Direct Infusion No antimicrobial agent or other substance has been added. Sterile. Pharmacy bulk package container.

WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques.

Mix thoroughly. Do not store. CONTAINS NO MORE THAN 25 mcg/L OF ALUMINUM Recommended Storage: Room temperature (25°C).

Avoid excessive heat. Protect from freezing. Do not remove overwrap until ready for use.

Once container closure has been penetrated, withdrawal of content should be completed within 4 hours. See Package Insert. Not made with natural rubber latex, PVC or DEHP.

Rx only Y38-000-065 LD-455-3 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 SET Sterile Water Injection 2L Container Label Recycle symbol Sterile Water Injection 2L Container Label

PRINCIPAL DISPLAY PANEL - 3000 mL STERILE WATER FOR INJECTION USP WARNING: HYPOTONIC AND HEMOLYTIC. DO NOT INJECT UNTIL MADE APPROXIMATELY ISOTONIC BY ADDITION OF APPROPRIATE SOLUTE. REF S8506 NDC 0264-7385-60 LOT EXP.

3000 mL Pharmacy Bulk Package Not For Direct Infusion No antimicrobial agent or other substance has been added. Sterile. Pharmacy bulk package container.

WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques.

Mix thoroughly. Do not store. CONTAINS NO MORE THAN 25 mcg/L OF ALUMINUM Recommended Storage: Room temperature (25°C).

Avoid excessive heat. Protect from freezing. Do not remove overwrap until ready for use.

Once container closure has been penetrated, withdrawal of content should be completed within 4 hours. See Package Insert. Not made with natural rubber latex, PVC or DEHP.

Rx only Y38-000-066 LD-456-3 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 SET Recycle symbol 3000 mL Container Label

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
6.5K
Units reimbursed last 4 qtrs
22.9M
Gross reimbursed last 4 qtrs
$2.69M
Avg / prescription
$413.47
Avg / unit
$0.1174
Latest quarter Q1 2026
1.8KRx
Fee-for-service vs managed care ⓘ
96% FFS
Fee-for-service · 6,280 Rx Managed care · 236 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported 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: 36,193 units · 288 per 100k residents IL Indiana: no data reported IN Ohio: 1,242,959 units · 10,547 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 14,589,920 units · 37,444 per 100k residents CA Utah: no data reported UT Colorado: 4,246,812 units · 72,249 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 82,049 units · 1,328 per 100k residents MD Connecticut: 56,221 units · 1,554 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 36,135 units · 790 per 100k residents LA Mississippi: no data reported MS Alabama: 627,750 units · 12,290 per 100k residents AL Georgia: 2,015,837 units · 18,278 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 11,737 units · 51.9 per 100k residents FL
Units reimbursed · per 100k residents
51.972,249
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 Colorado 72,249 /100k
2 California 37,444 /100k
3 Georgia 18,278 /100k
4 Alabama 12,290 /100k
5 Ohio 10,547 /100k
6 Connecticut 1,554 /100k
7 Maryland 1,328 /100k
8 Louisiana 790 /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.
3000 ml this page00264-7385-60 6,516 Rx · $2,694,169
2000 ml00264-7385-50 3,248 Rx · $1,068,484
Drug total (last 4 qtrs): 9,764 Rx · 29,285,038 units · $3,762,653 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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 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 (00264-7385-50). 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.
← 00264-5804-00 · B. 00264-7386-50 · 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.