Home › NDC Lookup › Ingredients › Sodium Chloride › 00409-1966-07
BACTERIOSTATIC SODIUM CHLORIDE 9 mg/mL Injection, Solution — NDC 00409-1966-07 package photo

BACTERIOSTATIC SODIUM CHLORIDE 9 mg/mL Injection, Solution

by Hospira, Inc. · 25 VIAL, MULTI-DOSE in 1 TRAY (0409-1966-07) / 30 mL in 1 VIAL, MULTI-DOSE (0409-1966-02)
NDC 00409-1966-07
🏷️ FDA NDC (as labeled) 0409-1966-07 billing pads the labeler segment with a zero
This package
Contains30 mL in 1 vial, multi-dose Medicaid pays$47.92 / unit · 12 mo Per package$35,939.33 / 750 ml · Medicaid Pack sizes3 compare ↓
Also comes in: 25 vials 00409-1966-05 25 vials 00409-1966-12
Rx only Brand On market Non-controlled
🗂️ 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

⚠️
Other active recalls for Sodium Chloride (different manufacturers) — 6 · 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 (Huons Co., Ltd.) · FDA recall D-0531-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0433-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0427-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0425-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0429-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0431-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0409-1966-07
Product NDC 0409-1966
11-digit billing NDC 00409196607
NCPDP billing unit ML — per mL (volume)
RxCUI 313002
UNII 451W47IQ8X
Application # NDA018800
SPL Set ID 376093e7-e09e-4a57-3199-195e45251866
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-04-30
Route INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance SODIUM CHLORIDE
GPI-14 98401040002010
GPI class Sodium Chloride Bacteriostatic
GCN Seq No 008528
GCN 56780
HICL code 003794
Ingredient (HICL) Bacteriostatic Sodium Chloride
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1B
Therapeutic class — specific (HIC3) Sodium/Saline Preparations
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name BACTERIOSTATIC SALINE VIAL
FDB brand name Sodium Chloride
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 0409-1966-07 — 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 → 00409-1966-07. 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.

🏷️ RxNorm drug class

This medicine belongs to the Sodium class.

Drug family (ATC) Sodium, Salt solutions, Electrolyte solutions
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerHospira, Inc.
Application holderHOSPIRA INC
FDA applicationNDA018800 (NDA)
Labeler code00409
First marketedApr 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 BACTERIOSTATIC SALINE VIAL Ingredient Bacteriostatic Sodium Chloride
📗 Our plain-language guide HelloPharmacist
  • Yes, exactly. Saline is just sodium chloride dissolved in water — it's essentially a sterile salt-water solution. Depending on the concentration and form, it can be used as an IV f...
  • I've heard of saline solution — is that the same thing as sodium chloride?
  • In some situations — like after surgery, during serious illness, or when someone can't take anything by mouth — the body needs fluids and electrolytes delivered directly into the b...
  • Why would someone need sodium chloride through an IV? Can't you just drink water?
📖 Read our full Sodium Chloride guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 9 mg / 1 mL UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $47.92 $35,939.33 / 750 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · A4216 No ASP payment limit on file for A4216 this quarter.
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)0409-1966-07
11-digit billing NDC00409-1966-07
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
Sodium Chloride 9 mg/mL 00409-4888-10 Hospira, 25 vials $0.088 AP Availability likely —
Bacteriostatic Sodium Chloride 9 mg/mL 00404-9953-10 Henry 1 vial — AP FDA listed —
Bacteriostatic Sodium Chloride 9 mg/mLthis 00409-1966-07 Hospira, 25 vials — AP FDA listed —
Bacteriostatic Sodium Chloride 9 mg/mL 51662-1259-01 HF 30 ml — AP FDA listed —
Bacteriostatic Sodium Chloride 9 mg/mL 63323-0924-10 Fresenius 25 vials — AP FDA listed —
Bacteriostatic Sodium Chloride 9 mg/mL 71872-7083-01 Medical 1 vial — AP FDA listed —
Bacteriostatic Sodium Chloride 9 mg/mL 84549-0966-07 ProPharma 30 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 71872-7248-01 Medical 1 vial — AP FDA listed —
Sodium Chloride 9 mg/mL 76420-0083-10 Asclemed 10 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 00641-0497-25 Hikma 25 vials — — FDA listed —
Sodium Chloride 9 mg/mL 51662-1464-01 HF 20 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 55154-0126-05 Cardinal 5 vials — AP Discontinued —
Sodium Chloride 9 mg/mL 00404-9954-20 Henry 1 vial — AP FDA listed —
Sodium Chloride 9 mg/mL 84549-0888-10 ProPharma 10 ml — AP FDA listed —
sodium chloride 9 mg/mL 64253-0202-30 Medefil, 60 syringes — — FDA listed —
Sodium Chloride 9 mg/mL 00641-6144-25 Hikma 25 vials — — FDA listed —
Sodium Chloride 9 mg/mL 65282-1505-01 Spectra 5 ampules — AP FDA listed —
Sodium Chloride 9 mg/mL 51662-1342-01 HF 10 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 65282-1510-01 Spectra 5 ampules — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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
Apr 2005
📍
2026
Currently FDA-listed
21 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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 00409-1966-07, 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
2.9K
Units reimbursed last 4 qtrs
117.3K
Gross reimbursed last 4 qtrs
$5.62M
Avg / prescription
$1,910.15
Avg / unit
$47.9192
Latest quarter Q4 2025
685Rx
Fee-for-service vs managed care ⓘ
56% FFS 44% MCO
Fee-for-service · 1,650 Rx Managed care · 1,292 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 1,613 units · 20.6 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 2,035 units · 34.4 per 100k residents WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 1,033 units · 24.4 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 1,650 units · 13.1 per 100k residents IL Indiana: 9,635 units · 140 per 100k residents IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 41,930 units · 108 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 7,621 units · 123 per 100k residents MO Kentucky: 45,626 units · 1,008 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 12 units · 0.6 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 6,118 units · 56.5 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.61,008
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 Kentucky 1,008 /100k
2 Indiana 140 /100k
3 Missouri 123 /100k
4 California 108 /100k
5 North Carolina 56.5 /100k
6 Wisconsin 34.4 /100k
7 Oregon 24.4 /100k
8 Washington 20.6 /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 vials this page00409-1966-07 2,942 Rx · $7,723,521
25 vials00409-1966-05 28 Rx · $340
25 vials00409-1966-12 11 Rx · $1,080
Drug total (last 4 qtrs): 2,981 Rx · 120,311 units · $7,724,940 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Sodium Chloride (matched by generic name) — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Sodium Chloride. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$16.2K
Claims incl. refills
266
Beneficiaries
53
Spend / beneficiary
$304.99
Spend / claim
$60.77
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00409-1966-05 25 VIAL, MULTI-DOSE in 1 TRAY (0409-1966-05) / 20 mL in 1 VIAL, MULTI-DOSE (0409-1966-01) $0.0667 / mL $33.34 2005-05-02 Active
00409-1966-07 You're viewing this 25 VIAL, MULTI-DOSE in 1 TRAY (0409-1966-07) / 30 mL in 1 VIAL, MULTI-DOSE (0409-1966-02) — — 2005-04-30 Active
00409-1966-12 25 VIAL, MULTI-DOSE in 1 TRAY (0409-1966-12) / 10 mL in 1 VIAL, MULTI-DOSE (0409-1966-06) — — 2005-10-07 Active

In Medicaid, this is the most-dispensed pack of this product — about 99% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00409-1966-07?
NDC 00409-1966-07 is listed by the FDA — 25 vial, multi-dose in 1 tray / 30 ml in 1 vial, multi-dose.
What NDC number is used to bill for this package of BACTERIOSTATIC SODIUM CHLORIDE 9 mg/mL Injection, Solution?
Bill NDC 00409-1966-07 — the 11-digit billing format is 00409196607. 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
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) ✓ 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 ✓ 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.
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 0409-1966-07, 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: 00409-1966-07, written without dashes as 00409196607. 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 00409-1966-07, the first segment (00409) is the labeler code FDA assigned to Hospira, Inc.; the middle segment (1966) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Hospira, 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 25 vials (00409-1966-05), 25 vials (00409-1966-12). 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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🚨 Boxed Warning 6 words ▾

WARNING: NOT FOR USE IN NEONATES.

🎯 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 58 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .

⛔ Contraindications 53 words ▾

CONTRAINDICATIONS Due to the potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol must not be used in this patient population. Parenteral preparations with benzyl alcohol should not be used for fluid or sodium chloride replacement. Parenteral preparations containing benzyl alcohol should not be used in epidural or spinal anesthetic procedures.

⚠️ Warnings 66 words ▾

WARNINGS Benzyl alcohol, a preservative in Bacteriostatic Sodium Chloride Injection, USP has been associated with toxicity in neonates. Data are unavailable on the toxicity of other preservatives in this age group. Preservative-free Sodium Chloride Injection should be used for flushing intravascular catheters.

Where a sodium chloride solution is required for preparing or diluting medications for use in neonates, only preservative-free Sodium Chloride Injection should be used.

🤒 Adverse Reactions 153 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.

Although adverse reactions to intravenous, intramuscular or subcutaneous injection of 0.9% benzyl alcohol are not known to occur in man, experimental studies of small volume parenteral preparations containing 0.9% benzyl alcohol in several species of animals have indicated that an estimated intravenous dose up to 30 mL may be safely given to an adult without toxic effects. Administration of an estimated 9 mL to a 6 kg neonate or infant is potentially capable of producing blood pressure changes.

🔄 Drug Interactions 84 words ▾

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

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

🤰 Pregnancy 61 words ▾

Pregnancy Animal reproduction studies have not been conducted with Bacteriostatic 0.9% Sodium Chloride Injection, USP. It is also not known whether Bacteriostatic 0.9% Sodium Chloride Injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bacteriostatic 0.9% Sodium Chloride Injection containing additives should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 45 words ▾

Pediatric Use The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. However, due to potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol are contraindicated in this patient population.

🆘 Overdosage 51 words ▾

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

🧬 Clinical Pharmacology 193 words ▾

CLINICAL PHARMACOLOGY Sodium chloride in water dissociates to provide sodium (Na + ) and chloride (Cl − ) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. The distribution and excretion of sodium (Na + ) and chloride (Cl − ) are largely under the control of the kidney which maintains a balance between intake and output.

The small volume of fluid and amount of sodium chloride provided by Bacteriostatic 0.9% Sodium Chloride Injection, USP, when used only as a vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and very small infants. 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 distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium.

📦 How Supplied / Storage and Handling 94 words ▾

HOW SUPPLIED Bacteriostatic 0.9% Sodium Chloride Injection, USP is supplied as: Unit of Sale Concentration NDC 0409-1966-05 0.9% (20 mL) Tray of 25 Multiple-dose Plastic Fliptop Vials NDC 0409-1966-07 0.9% (30 mL) Tray of 25 Multiple-dose Plastic Fliptop Vials NDC 0409-1966-12 0.9% (10 mL) Tray of 25 Multiple-dose LifeShield ® Plastic Fliptop Vials Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] LIFESHIELD ® is the trademark of ICU Medical, Inc. and is used under license. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1096-3.0 Revised: 02/2019 Hospira Logo

📋 Description 165 words ▾

DESCRIPTION This preparation is designed for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride in water for injection. Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) benzyl alcohol added as a bacteriostatic preservative.

May contain hydrochloric acid for pH adjustment. It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for medication. The pH is 5.0 (4.5 to 7.0).

Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. 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 drug concentration.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00409-1902-01 · Hospira, 00409-1983-10 · 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.