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Sterile Water 1 mL/mL Injection — NDC 00404-9959-50 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 0404-9959-50 (Billing 00404-9959-50)

by Henry Schein, Inc. · 1 VIAL, SINGLE-DOSE in 1 BAG / 50 mL in 1 VIAL, SINGLE-DOSE

This is a package of Sterile Water 1 mL/mL Injection from Henry Schein, Inc., marketed since Jan 2022 and currently FDA-listed.

NDC 00404-9959-50
🏷️ FDA NDC (as labeled) 0404-9959-50 billing pads the labeler segment with a zero
This package
Contains50 mL in 1 vial, single-dose Pack sizes3 compare ↓
Product page 00404-9959-10 Also comes in: 10 mL 0404-9959-10 20 mL 0404-9959-20
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

⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0404-9959-50
Product NDC 0404-9959
11-digit billing NDC 00404995950
UNII 059QF0KO0R
Application # NDA018801
SPL Set ID 88403fcf-a276-42c0-88b6-bd84a720b564
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-01-12
Route INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION
Substance WATER
Why two NDCs? The FDA registers this code as 0404-9959-50 — 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 → 00404-9959-50. 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

📗 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: 10 mL 20 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
00404-9959-10 0404-9959-10 Main listing 1 VIAL, SINGLE-DOSE in 1 BAG / 10 mL in 1 VIAL, SINGLE-DOSE 2022-01-12 Aug 31, 2027 Active
00404-9959-20 0404-9959-20 1 VIAL, SINGLE-DOSE in 1 BAG / 20 mL in 1 VIAL, SINGLE-DOSE 2022-01-12 — Active
00404-9959-50 You're viewing this 1 VIAL, SINGLE-DOSE in 1 BAG / 50 mL in 1 VIAL, SINGLE-DOSE 2022-01-12 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 vial, single-dose in 1 bag / 50 ml in 1 vial, single-dose.
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 00409-4887-10 Hospira, 25 vials $0.315 — Availability likely —
Sterile Water 1 mL/mL 00409-0024-10 Hospira, 25 vials $0.315 — 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/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/mLthis 00404-9959-50 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

🏛️
2022
On the market since
Jan 2022
📍
2026
Currently FDA-listed
4 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.

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

LabelerHenry Schein, Inc.
Application holderHOSPIRA INC
FDA applicationNDA018801 (NDA)
Labeler code00404
First marketedJan 2022
Product typeHuman Prescription Drug
Portfolio172 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.

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 📄 Package Label / Principal Display Panel
🎯 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 patients, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.

🆘 Overdosage 49 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 appropriated corrective measures. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS .

🧬 Clinical Pharmacology 123 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 concentrations 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 152 words ▾

HOW SUPPLIED Sterile Water for Injection, USP is supplied in the following: Store at 20 to 25C (68 to 77F). [See USP Controlled Room Temperature.] Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 0409-4887-10 Tray of 25 Single-Dose Plastic Fliptop Vials NDC 0404-9959-10 1 10 mL Single-Dose Plastic Fliptop Vial in a bag (Vial bears NDC 0409-4887-17) 10 mL NDC 0409-4887-20 Tray of 25 Single-Dose Plastic Fliptop Vials NDC 0404-9959-20 1 20 mL Single-Dose Plastic Fliptop Vial in a bag (Vial bears NDC 0409-4887-23) 20 mL NDC 0409-4887-50 Tray of 25 Single-Dose Plastic Fliptop Vials NDC 0404-9959-50 1 50 mL Single-Dose Plastic Fliptop Vial in a bag (Vial bears NDC 0409-4887-24) 50 mL Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1292-2.0 Revised: 05/2021 Image1.jpg

📋 Description 159 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 H2O. 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.

⚠️ Precautions ~1 min read ▾

Precautions Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture. Consult the manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration.

Pregnancy Category C. 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 Safety and effectiveness have been established in pediatric patients. However, in neonates for very small infants the volume of fluid may affect fluid and electrolyte balance.

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.

📄 Package Label / Principal Display Panel 6 words ▾

SAMPLE PACKAGE LABEL Label1.jpg Label2.jpg Label3.jpg

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

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 — 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 — 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 Henry Schein, 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 2 other package presentations of this same product, including 1 vial (00404-9959-10), 1 vial (00404-9959-20). 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?
Henry Schein, 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.
← 00404-9958-01 · Henry 00404-9961-25 · Henry →
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.