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Water 1 mL/mL Injection, Solution — NDC 52919-005-05 (Billing 52919-0005-05)

by Siegfried Hameln GmbH · 50 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS

This is a package of Water 1 mL/mL Injection, Solution from Siegfried Hameln GmbH, marketed since Aug 2019 and currently FDA-listed. It is this product's only package size.

NDC 52919-0005-05
🏷️ FDA NDC (as labeled) 52919-005-05 billing pads the product segment with a zero
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) 52919-005-05
Product NDC 52919-005
11-digit billing NDC 52919000505
SPL Set ID 45aee4cf-364b-cd1d-e063-6394a90a2a00
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-08-07
Dosage form INJECTION, SOLUTION
Substance WATER

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

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 STERILE WATER (SHIRE)
FDB brand name Sterile Water (Shire)
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001167
  • GCN: 02709
  • HICL (First Databank): 000517
  • AHFS class code: 96:00.00.00
Why two NDCs? The FDA registers this code as 52919-005-05 — 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 → 52919-0005-05. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name STERILE WATER (SHIRE) 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 mLPer 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
52919-0005-05 You're viewing this Main listing 50 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS — — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sterile Water 1 mL/mL 00517-3020-25 American 25 vials $0.066 — FDA listed —
Sterile Water 1 mL/mL 00517-3010-25 American 25 vials $0.315 — Availability likely —
Sterile Water 1 mL/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 00264-7385-50 B. 2000 ml — AP FDA listed —
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 —
Water 1 mL/mL 52919-0037-05 Siegfried 50 vials — — FDA listed —
Water 1 mL/mL 63552-0134-00 Patheon 481 vials — — FDA listed —
Sterile Water 1 mL/mL 17271-0802-07 Becton 1000 ml — AT FDA listed —
Sterile Diluent for Treprostinil 1 mL/mL 43598-0126-11 Dr.Reddy's 1 vial — AP FDA listed —
Sterile Water 1 mL/mL 65219-0499-30 Fresenius 3000 ml — AT FDA listed —
Sterile Diluent for Remodulin 1 mL/mL 66302-0150-50 United 1 vial — — FDA listed —
Sterile Water 1 mL/mL 00990-7118-07 ICU 2000 ml — AP FDA listed —
Water 1 mL/mL 52919-0006-05 Siegfried 50 vials — — FDA listed —
Sterile Water 1 mL/mL 00404-9971-00 Henry 1 vial — — FDA listed —
water 1 mL/mL 52919-0009-15 Siegfried 230 vials — — FDA listed —
Water 1 mL/mL 52919-0014-04 Siegfried 25 vials — — FDA listed —
Water 1 mL/mL 52919-0032-05 Siegfried 50 vials — — FDA listed —
Water 1 mL/mL 52919-0038-05 Siegfried 50 vials — — FDA listed —
Water 1 mL/mL 52919-0042-16 Siegfried 300 vials — — FDA listed —
Water 1 mL/mL 84502-0112-01 Fujian 1 ml — — 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 —
water 1 mL/mL 00662-4887-03 Hospira, 25 vials — — FDA listed —
Water 1 mL/mL 52919-0033-16 Siegfried 300 vials — — FDA listed —
Water 1 mL/mL 63552-0287-00 Patheon 84 vials — — FDA listed —
Sterile Water 1 mL/mL 00404-9959-10 Henry 1 vial — — FDA listed —
Sterile Water 1 mL/mL 84549-0850-10 ProPharma 500 ml — AP FDA listed —
Water 1 mL/mLthis 52919-0005-05 Siegfried 50 vials — — FDA listed —
Water 1 mL/mL 52919-0041-16 Siegfried 300 vials — — FDA listed —
Sterile Water 1 mL/mL 00264-7850-00 B. 1000 ml — AP FDA listed —
Sterile Water 1 mL/mL 65219-0495-10 Fresenius 1000 ml — AT FDA listed —
Water 1 mL/mL 52919-0043-04 Siegfried 25 vials — — FDA listed —
Water 1 mL/mL 52919-0044-04 Siegfried 25 vials — — FDA listed —
Water 1 mL/mL 52919-0045-04 Siegfried 36 vials — — FDA listed —
Sterile Water 1 mL/mL 55154-0127-05 Cardinal 5 vials — — FDA listed —
Sterile Water 1 mL/mL 65219-0497-20 Fresenius 2000 ml — AT FDA listed —
Sterile Water 1 mL/mL 84549-0887-50 ProPharma 50 ml — — FDA listed —
Water 1 mL/mL 52919-0003-05 Siegfried 50 vials — — FDA listed —
Bacteriostatic Water 1 mL/mL 00404-9970-30 Henry 1 vial — AP FDA listed —
INSULIN DILUTING MEDIUM FOR Kirsty 1 mL/mL 83257-0006-11 Biocon 1 vial — — FDA listed —
Water 1 mL/mL 52919-0008-05 Siegfried 50 vials — — FDA listed —
Water 1 mL/mL 52919-0011-04 Siegfried 25 vials — — FDA listed —
Water 1 mL/mL 52919-0034-16 Siegfried 300 vials — — FDA listed —
Water 1 mL/mL 52919-0039-17 Siegfried 36 vials — — FDA listed —
Water 1 mL/mL 52919-0040-18 Siegfried 20 vials — — FDA listed —
Water 1 mL/mL 63552-0286-00 Patheon 84 vials — — FDA listed —
water 1 mL/mL 84502-0106-01 Fujian 1 ml — — Discontinued —
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: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where 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

🏛️
2019
On the market since
Aug 2019
📍
2026
Currently FDA-listed
7 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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

LabelerSiegfried Hameln GmbH
Labeler code52919
First marketedAug 2019
Product typeDrug For Further Processing
Portfolio25 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 FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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 Water — the ingredient across all brands.

Top reported reactions

Nausea1,170
Pyrexia1,048
Pain973
Diarrhoea844
Dyspnoea844
Fatigue796
Vomiting772

Age at onset

Neonate416
Infant79
Child265
Adolescent188
Adult2,500
Elderly913

Reporter sex

19,136 reports
Male · 39%
Female · 61%
Unknown · 0%

Serious outcomes

Hospitalization8,572
Death2,299
Life-threatening2,087
Disabling440
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1,567 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

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Siegfried Hameln GmbH supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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 — Not published for this NDC No photo available yet for this listing.
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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
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 Siegfried Hameln GmbH. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Siegfried Hameln GmbH 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.
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.
← 52919-0003-05 · Siegfried 52919-0006-05 · Siegfried →
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.