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Sterile Water 1 mL/mL Injection — NDC 00409-4887-99 package photo

Sterile Water 1 mL/mL Injection

by Hospira, Inc. · 25 VIAL, GLASS in 1 CASE (0409-4887-99) / 100 mL in 1 VIAL, GLASS (0409-4887-25)
NDC 00409-4887-99
🏷️ FDA NDC (as labeled) 0409-4887-99 billing pads the labeler segment with a zero
This package
Contains100 mL in 1 vial, glass Medicaid pays$2.96 / unit · 12 mo Per package$74.07 / 25 vials · Medicaid Pack sizes5 compare ↓
Also comes in: 25 vials 00409-4887-10 25 vials 00409-4887-20 25 vials 00409-4887-50 30 vials 00409-4887-34
Rx only Brand Discontinued Non-controlled ⚠ On shortage ⚠ Discontinued by firm
🗂️ 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 →

This page is curated, coded, and maintained by

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

⚠️
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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2015. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 0409-4887-99
Product NDC 0409-4887
11-digit billing NDC 00409488799
NCPDP billing unit ML — per mL (volume)
UNII 059QF0KO0R
Application # NDA018801
SPL Set ID 2b9ea23a-f9e9-48a8-25b7-519e3bbd6828
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2015)
Marketing start 2005-06-16
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
Why two NDCs? The FDA registers this code as 0409-4887-99 — 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 → 00409-4887-99. 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

LabelerHospira, Inc.
Application holderHOSPIRA INC
FDA applicationNDA018801 (NDA)
Labeler code00409
First marketedJun 2005
Product typeHuman Prescription Drug
Portfolio317 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 →

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.

🧪 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 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 $2.96 $74.07 / 25 vials
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.
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)0409-4887-99
11-digit billing NDC00409-4887-99
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler 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/mL 00409-0024-10 Hospira, 25 vials $0.308 — Availability likely —
Sterile Water 1 mL/mL 63323-0185-05 Fresenius 25 vials — AP FDA listed —
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/mLthis 00409-4887-99 Hospira, 25 vials — — Discontinued —
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 the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2005
On the market since
Jun 2005
📍
2026
Currently FDA-listed
21 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 00409-4887-99, 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
901
Units reimbursed last 4 qtrs
72.3K
Gross reimbursed last 4 qtrs
$214.1K
Avg / prescription
$237.66
Avg / unit
$2.9629
Latest quarter Q4 2025
248Rx
Fee-for-service vs managed care ⓘ
73% FFS 27% MCO
Fee-for-service · 661 Rx Managed care · 240 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: 22,700 units · 181 per 100k residents IL Indiana: no data reported IN Ohio: 2,841 units · 24.1 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 19,871 units · 51.0 per 100k residents CA Utah: no data reported UT Colorado: 7,500 units · 128 per 100k residents CO Nebraska: no data reported NE Missouri: 8,126 units · 131 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 11,233 units · 182 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 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: 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: no data reported FL
Units reimbursed · per 100k residents
24.1182
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 Maryland 182 /100k
2 Illinois 181 /100k
3 Missouri 131 /100k
4 Colorado 128 /100k
5 California 51.0 /100k
6 Ohio 24.1 /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 vials00409-4887-10 17,247 Rx · $11,567,511
25 vials00409-4887-20 7,369 Rx · $3,967,620
25 vials00409-4887-50 2,726 Rx · $186,983
25 vials this page00409-4887-99 901 Rx · $214,130
30 vials00409-4887-34 No Medicaid data
Drug total (last 4 qtrs): 28,243 Rx · 3,353,940 units · $15,936,244 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
00409-4887-10 25 VIAL, PLASTIC in 1 TRAY (0409-4887-10) / 10 mL in 1 VIAL, PLASTIC (0409-4887-17) $0.3076 / mL $76.90 2005-08-01 Active
00409-4887-20 25 VIAL, PLASTIC in 1 TRAY (0409-4887-20) / 20 mL in 1 VIAL, PLASTIC (0409-4887-23) $0.0661 / mL $33.03 2005-06-16 Active
00409-4887-34 30 VIAL, PLASTIC in 1 TRAY (0409-4887-34) / 10 mL in 1 VIAL, PLASTIC (0409-4887-32) — — 2015-07-30 Active
00409-4887-50 25 VIAL, PLASTIC in 1 TRAY (0409-4887-50) / 50 mL in 1 VIAL, PLASTIC (0409-4887-24) — — 2005-08-04 Active
00409-4887-99 You're viewing this 25 VIAL, GLASS in 1 CASE (0409-4887-99) / 100 mL in 1 VIAL, GLASS (0409-4887-25) — — 2005-08-03 Discontinued by firm

This pack accounts for about 3.2% 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 00409-4887-99?
NDC 00409-4887-99 is listed by the FDA — 25 vial, glass in 1 case / 100 ml in 1 vial, glass.
What NDC number is used to bill for this package of Sterile Water 1 mL/mL Injection?
Bill NDC 00409-4887-99 — the 11-digit billing format is 00409488799. 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.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 0409-4887-99, 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: 00409-4887-99, written without dashes as 00409488799. 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 00409-4887-99, the first segment (00409) is the labeler code FDA assigned to Hospira, Inc.; the middle segment (4887) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (99) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 25 vials (00409-4887-10), 25 vials (00409-4887-20), 25 vials (00409-4887-50). 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?
Hospira, 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 A4216 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 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 14 words ▾

CONTRAINDICATIONS Sterile Water for Injection, USP 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.

🆘 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 125 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 (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms.

Water for 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 125 words ▾

HOW SUPPLIED Sterile Water for Injection, USP is a sterile, clear, and colorless water for injection, available as a single-dose vial, and is supplied in the following: Unit of Sale Total Content NDC 0409-4887-05 Tray of 25 Single-dose Glass Fliptop Vials 1 mL NDC 0409-4887-10 Tray of 25 Single-dose Plastic Fliptop Vials 10 mL NDC 0409-4887-34 Tray of 30 Single-dose Plastic Fliptop Vials 10 mL NDC 0409-4887-20 Tray of 25 Single-dose Plastic Fliptop Vials 20 mL NDC 0409-4887-50 Tray of 25 Single-dose Plastic Fliptop Vials 50 mL NDC 0409-4887-99 Case of 25 Single-dose Glass Fliptop Vials 100 mL Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1292-4.0 Revised: 03/2026 Hospira logo

📋 Description 161 words ▾

DESCRIPTION This preparation is designed solely for parenteral use only after addition of 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 I.V. injection, add sufficient solute to make an approximately isotonic solution.

Water for Injection, USP is chemically designated H 2 O. The glass vial is Type I or II borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. The semi-rigid vial is fabricated from a specially formulated polyolefin.

It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper labeled volume.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00409-4883-01 · Hospira, 00409-4888-10 · Hospira, →
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.