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Sterile Water 1 mL/mL Injection — NDC 00487-6105-01 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 0487-6105-01 (Billing 00487-6105-01)

by Nephron Pharmaceuticals Corporation · 30 VIAL, PLASTIC in 1 CARTON / 5 mL in 1 VIAL, PLASTIC

This is a package of Sterile Water 1 mL/mL Injection from Nephron Pharmaceuticals Corporation, marketed since Jun 2021 and currently FDA-listed. It is this product's only package size.

NDC 00487-6105-01
🏷️ FDA NDC (as labeled) 0487-6105-01 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled ⚠ On shortage ⇄ 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 0487-6105-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0487 labeler · 6105 product · 01 package
Package marketed since
Jun 16, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0304876105013
FDA record last changed
Jul 24, 2026
⚠️
Active FDA shortage. Sterile Water Injection is currently reported in shortage by the FDA (Other). Limited Availability Shortage details →
Past resolved recalls for this product (2)
Class II · Feb 23, 2023 · Terminated — CGMP Deviations: Potential product carryover. (Nephron Sc Inc) · FDA recall D-0364-2023
Class II · Jan 12, 2023 · Terminated — CGMP Deviations: potential for trace amounts of product carryover. (Nephron Sc Inc) · FDA recall D-0178-2023

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0487-6105-01
Product NDC 0487-6105
11-digit billing NDC 00487610501
NCPDP billing unit ML — per mL (volume)
UNII 059QF0KO0R
UPC 0304876105013
Application # ANDA211222
SPL Set ID bc04a883-babc-87a6-e053-2995a90a3dfd
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-06-07
Route INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
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 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
Quick answers
  • GSN (GCN sequence number): 001167
  • GCN: 02709
  • 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 0487-6105-01 — 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 → 00487-6105-01. 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 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.

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.
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
00487-6105-01 You're viewing this Main listing 30 VIAL, PLASTIC in 1 CARTON / 5 mL in 1 VIAL, PLASTIC 2021-06-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sterile Water 1 mL/mL 51662-1329-01 HF 10 ml — — FDA listed —
Sterile Water 1 mL/mL 51662-1266-01 HF 100 ml — — FDA listed —
Sterile Water 1 mL/mL 51662-1474-01 HF 20 ml — — FDA listed —
Sterile Water 1 mL/mLthis 00487-6105-01 Nephron 30 vials — AP FDA listed —
Sterile Water 1 mL/mL 62135-0833-84 Chartwell 30 vials — AP FDA listed —
Sterile Water 1 mL/mL 51662-1265-01 HF 50 ml — — 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

🏛️
2021
On the market since
Jun 2021
📍
2026
Currently FDA-listed
5 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.

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

LabelerNephron Pharmaceuticals Corporation
Application holderNEPHRON PHARMACEUTICALS CORPORATION
FDA applicationANDA211222 (ANDA)
Labeler code00487
First marketedJun 2021
Product typeHuman Prescription Drug
Portfolio12 products on file

More NDCs from Nephron Pharmaceuticals Corporation labeler code 00487

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 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 29 words ▾

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 60 words ▾

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. Please refer to INSTRUCTIONS FOR USE for administration instructions.

⛔ Contraindications 12 words ▾

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

⚠️ Warnings 14 words ▾

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

🤒 Adverse Reactions 73 words ▾

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 81 words ▾

Some drugs for injection may be incompatible in a given vehicle, when combined in the same vehicle, or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available. Use aseptic technique for withdrawal from the container.

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.

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

🤰 Pregnancy 52 words ▾

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

🧒 Pediatric Use 26 words ▾

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 47 words ▾

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 119 words ▾

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average 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 when used only as a pharmaceutical 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 45 words ▾

Sterile Water for Injection, USP is supplied in 5 mL vials, packaged in cartons as follows: NDC 0487-6105-01, 30 individual 5 mL single-dose luer-lock vials. Discard unused portion. Each vial is made from a polypropylene (PP) resin. Store at 2°C to 25°C (36°F to 77°F).

📋 Description 141 words ▾

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 intravenous injection, dissolve sufficient solute to make an approximately isotonic solution.

Water for Injection, USP is chemically designated H2O. pH 5.0 to 7.0. The plastic single-dose vial is fabricated from polypropylene resin. The plastic vials feature a twist-off cap which, when removed, allows access to a luer-lock fitting for connection to a luer-lock syringe.

The twist-off cap is a one-time use tamper evident feature, and the container vial cannot be reclosed once the cap is removed.

⚠️ Precautions ~1 min read ▾

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.

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

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. Some drugs for injection may be incompatible in a given vehicle, when combined in the same vehicle, or in a vehicle containing benzyl alcohol.

Consult with pharmacist, if available. Use aseptic technique for withdrawal from the container. 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. Do not reuse single-dose containers.

Discard unused portion.

📖 Instructions for Use 57 words ▾

Sterile Water for Injection, USP 5 mL Single-Dose Luer-Lock Vial Read complete instructions carefully before using. USE ASEPTIC TECHNIQUE and instructions for use. A sterile luer-lock syringe (not included) must be separately obtained for use with the luer-lock vial. Use aseptic technique throughout the Infor the withdrawal of the contents from the luer-lock vial. Instructions for Use

📄 Package Label / Principal Display Panel 7 words ▾

Vial Sleeve Sterile Water for Injection Carton

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for STERILE WATER — the ingredient across all brands.

Top reported reactions

Hereditary Angioedema576
Nausea267
Fatigue265
Headache254
Weight Increased232
Pyrexia226
Weight Decreased221

Age at onset

Neonate14
Infant16
Child196
Adolescent145
Adult1,465
Elderly212

Reporter sex

0 reports

Serious outcomes

Life-threatening148
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 599 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Nephron Pharmaceuticals Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Nephron Pharmaceuticals Corporation 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.
← 00487-5901-99 · Nephron 00487-6232-01 · Nephron →
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.