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Sterile Water 1 mL/mL Injection — NDC 63323-0185-20 package photo

Sterile Water 1 mL/mL Injection

by Fresenius Kabi USA, LLC · 25 VIAL in 1 TRAY (63323-185-20) / 20 mL in 1 VIAL (63323-185-08)
NDC 63323-0185-20
🏷️ FDA NDC (as labeled) 63323-185-20 billing pads the product segment with a zero
This package
Contains20 mL in 1 vial Cost per mL$0.0661 NADAC Per package$33.05 / 500 ml Pack sizes4 compare ↓
Also priced by: Medicaid pays $9.97/unit — full pricing hub ↓
Rx only Generic 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 Injection 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) 63323-185-20
Product NDC 63323-185
11-digit billing NDC 63323018520
NCPDP billing unit ML — per mL (volume)
UNII 059QF0KO0R
UPC 0363323185084, 0363323185077, 0363323185046
Application # ANDA088400
SPL Set ID e71c6c83-d518-496c-b2ab-efd5987e4783
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2000-09-05
Route INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION
Substance WATER
GPI-14 98401010002000
GPI class Sterile Water for Injection
GCN Seq No 001167
GCN 02709
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 WATER FOR INJECTION VIAL
FDB brand name Water
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 63323-185-20 — a 5-3-2 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 product segment → 63323-0185-20. 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

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationANDA088400 (ANDA)
Labeler code63323
First marketedSep 2000
Product typeHuman Prescription Drug
Portfolio554 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 WATER FOR INJECTION VIAL 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 →
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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.066 $33.05 / 500 ml
Medicaid paysCMS SDUD · 12 mo $9.97 $4,982.90 / 500 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · A4216 No ASP payment limit on file for A4216 this quarter.
NADAC price history (per mL) — tap or hover for the price & month
Oct 2023 Feb 2025 $0.066 $0.061
▲ Up 8% over the last 2 months.
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)63323-185-20
11-digit billing NDC63323-0185-20
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeA4216
DescriptorSTERILE WATER, SALINE AND/OR DEXTROSE, DILUENT/FLUSH, 10 ML
Billing units / pkg0.1 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sterile Water 1 mL/mLthis 63323-0185-20 Fresenius 25 vials $0.066 AP Availability likely
Sterile Water 1 mL/mL 00409-4887-10 Hospira, 25 vials $0.308 Availability likely +366%
Sterile Water 1 mL/mL 00409-0024-10 Hospira, 25 vials $0.308 Availability likely +366%
Sterile Water 1 mL/mL 65219-0187-10 Fresenius 25 vials AP FDA listed
Sterile Water 1 mL/mL 76420-0082-10 Asclemed 10 ml FDA listed
Bacteriostatic Water 1 mL/mL 71872-7129-01 Medical 1 vial AP FDA listed
Sterile Water 1 mL/mL 72572-0747-10 Civica, 10 vials AP FDA listed
Sterile Water 1 mL/mL 00404-9971-00 Henry 1 vial FDA listed
Sterile Water 1 mL/mL 50090-2874-01 A-S 25 vials FDA listed
Sterile Water 1 mL/mL 55154-9588-05 Cardinal 5 vials AP FDA listed
Sterile Water 1 mL/mL 00641-6147-10 Hikma 10 vials AP FDA listed
Sterile Water 1 mL/mL 00404-9959-10 Henry 1 vial FDA listed
Sterile Water 1 mL/mL 55154-0127-05 Cardinal 5 vials FDA listed
Sterile Water 1 mL/mL 84549-0887-50 ProPharma 50 ml FDA listed
Bacteriostatic Water 1 mL/mL 00404-9970-30 Henry 1 vial AP FDA listed
Sterile Water 1 mL/mL 71872-7290-01 Medical 1 vial FDA listed
Sterile Water 1 mL/mL 70518-4732-01 REMEDYREPACK 25 vials FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2000
On the market since
Sep 2000
📍
2026
Currently FDA-listed
26 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 63323-0185-20, 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
809
Units reimbursed last 4 qtrs
22K
Gross reimbursed last 4 qtrs
$218.9K
Avg / prescription
$270.62
Avg / unit
$9.9656
Latest quarter Q4 2025
257Rx
Medicaid pays / mL
$9.9656
gross reimbursed
vs
NADAC / mL
$0.0661
acquisition cost
=
Spread
+$9.8995
+14977% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
93% FFS
Fee-for-service · 754 Rx Managed care · 55 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: 158 units · 2.7 per 100k residents 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: no data reported IL Indiana: no data reported IN Ohio: 85 units · 0.7 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 7,214 units · 18.5 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 13,265 units · 214 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 662 units · 7.6 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported 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: 405 units · 3.7 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 180 units · 0.8 per 100k residents FL
Units reimbursed · per 100k residents
0.7214
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 Missouri 214 /100k
2 California 18.5 /100k
3 Virginia 7.6 /100k
4 North Carolina 3.7 /100k
5 Wisconsin 2.7 /100k
6 Florida 0.8 /100k
7 Ohio 0.7 /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.
25 vials63323-0185-10 5,706 Rx · $1,026,412
25 vials this page63323-0185-20 809 Rx · $218,930
25 vials63323-0185-05 574 Rx · $10,843
25 vials63323-0185-50 No Medicaid data
Drug total (last 4 qtrs): 7,089 Rx · 237,956 units · $1,256,185 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

Hereditary Angioedema578
Fatigue304
Nausea299
Headache275
Pyrexia251
Pain245
Weight Decreased243

Age at onset

Neonate16
Infant16
Child204
Adolescent149
Adult1,553
Elderly251

Reporter sex

5,672 reports
Male · 37%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization1,709
Death203
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 768 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
63323-0185-05 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-185-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-185-04) 2022-04-30 Active
63323-0185-10 25 VIAL in 1 TRAY (63323-185-10) / 10 mL in 1 VIAL (63323-185-07) $0.3076 / mL $76.90 2000-09-05 Active
63323-0185-20 You're viewing this 25 VIAL in 1 TRAY (63323-185-20) / 20 mL in 1 VIAL (63323-185-08) $0.0661 / mL $33.03 2000-09-05 Active
63323-0185-50 25 VIAL in 1 TRAY (63323-185-50) / 50 mL in 1 VIAL (63323-185-09) 2000-09-05 Active

This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.0661 NADAC).

This pack accounts for about 11% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 63323-0185-20?
NDC 63323-0185-20 is listed by the FDA — 25 vial in 1 tray / 20 ml in 1 vial.
What NDC number is used to bill for this package of Sterile Water 1 mL/mL Injection?
Bill NDC 63323-0185-20 — the 11-digit billing format is 63323018520. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 32 words

INDICATIONS AND USAGE This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

⏱️ Dosage and Administration 54 words

DOSAGE AND ADMINISTRATION The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Contraindications 13 words

CONTRAINDICATIONS Sterile Water for Injection must be made approximately isotonic prior to use.

⚠️ Warnings 15 words

WARNINGS Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis.

🤒 Adverse Reactions 75 words

ADVERSE REACTIONS Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.

🔄 Drug Interactions 92 words

Drug Interactions Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available. Use aseptic technique for single or multiple entry and withdrawal from all containers.

When diluting or dissolving drugs, mix thoroughly and use promptly. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Do not use unless the solution is clear and seal intact.

Do not reuse single-dose containers. Discard unused portion.

🤰 Pregnancy 55 words

Pregnancy Animal reproduction studies have not been conducted with Sterile Water for Injection. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 28 words

Pediatric Use Safety and effectiveness have been established in pediatric patients. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.

🆘 Overdosage 50 words

OVERDOSAGE Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures (see WARNINGS , PRECAUTIONS and ADVERSE REACTIONS ).

🧬 Clinical Pharmacology 124 words

CLINICAL PHARMACOLOGY Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms.

Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium. The small volume of fluid provided by Sterile Water for Injection, USP when used only as a pharmaceutic aid for diluting or dissolving drugs for parenteral injection, is unlikely to exert a significant effect on fluid balance except possibly in neonates or very small infants.

📦 How Supplied / Storage and Handling 156 words

HOW SUPPLIED Product Code Unit of Sale Volume Each 918510 NDC 63323-185-10 Unit of 25 10 mL in a 10 mL vial NDC 63323-185-07 10 mL Single Dose Vial 918520 NDC 63323-185-20 Unit of 25 20 mL in a 20 mL vial NDC 63323-185-08 20 mL Single Dose Vial 918550 NDC 63323-185-50 Unit of 25 50 mL in a 50 mL vial NDC 63323-185-09 50 mL Single Dose Vial 187100 NDC 65219-187-10 Unit of 25 100 mL in a 100 mL vial NDC 65219-187-01 100 mL Single Dose Vial 18505 NDC 63323-185-05 Unit of 25 5 mL in a 6 mL vial NDC 63323-185-04 5 mL Single Dose Vial Packaged in a plastic vial.

Vials are packaged 25 vials per tray. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Single dose use.

No preservative added. Unused portion of vial should be discarded. Use only if solution is clear and seal intact.

📋 Description 95 words

DESCRIPTION This preparation is designed solely for parenteral use only after addition to drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single dose containers to dilute or dissolve drugs for injection. For IV injection, add sufficient amount to a solute to make an approximately isotonic solution. pH 5.0 to 7.0.

Water for Injection, USP is chemically designated H 2 O.

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.