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Sodium Chloride 9 mg/mL Injection, Solution — NDC 00264-1800-31 package photo

Sodium Chloride 9 mg/mL Injection, Solution

by B. Braun Medical Inc. · 84 CONTAINER in 1 CASE (0264-1800-31) / 50 mL in 1 CONTAINER
NDC 00264-1800-31
🏷️ FDA NDC (as labeled) 0264-1800-31 billing pads the labeler segment with a zero
This package
Contains50 mL in 1 container Medicaid pays$0.5085 / unit · 12 mo Per package$2,135.70 / 4200 ml · Medicaid Pack sizes3 compare ↓
Also priced by: Part D plans $0.0121/unit — full pricing hub ↓
Also comes in: 25 ml 00264-1800-36 100 ml 00264-1800-32
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) 0264-1800-31
Product NDC 0264-1800
11-digit billing NDC 00264180031
NCPDP billing unit ML — per mL (volume)
RxCUI 1807630, 1807631, 1807632
UNII 451W47IQ8X
Application # NDA017464
SPL Set ID cc14fafd-3dcd-4fc8-bdbd-6f355c375768
Established class (EPC) Osmotic Laxative
Mechanism of action Osmotic Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1978-02-08
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance SODIUM CHLORIDE
GPI-14 79750010002021
GPI class Sodium Chloride
GCN Seq No 001210
GCN 02962
HICL code 008255
Ingredient (HICL) 0.9 % 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 SODIUM CHLORIDE 0.9% SOLUTION
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 0264-1800-31 — 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 → 00264-1800-31. 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

LabelerB. Braun Medical Inc.
Application holderB BRAUN MEDICAL INC
FDA applicationNDA017464 (NDA)
Labeler code00264
First marketedFeb 1978
Product typeHuman Prescription Drug
Portfolio94 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 SODIUM CHLORIDE 0.9% SOLUTION Ingredient 0.9 % 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.

  • 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.

2 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 $0.5085 $2,135.70 / 4200 ml
Medicare drug plans payPart D · Q2 2026 $0.0121 $50.82 / 4200 ml
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)0264-1800-31
11-digit billing NDC00264-1800-31
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/mLthis 00264-1800-31 B. 50 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 00264-9375-88 B. 10 ml — AP FDA listed —
0.9% Sodium Chloride 9 mg/mL 51662-1577-01 HF 500 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 63323-0186-02 Fresenius 25 vials — — FDA listed —
Sodium Chloride 9 mg/mL 63323-0632-40 Fresenius 1000 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 65219-0328-50 Fresenius 1000 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 65219-0432-85 Fresenius 500 ml — AP FDA listed —
Sodium chloride 9 mg/mL 65219-0466-60 Fresenius 50 ml — AP FDA listed —
Sodium chloride 9 mg/mL 65219-0468-50 Fresenius 100 ml — AP FDA listed —
Sodium chloride 9 mg/mL 65219-0470-30 Fresenius 250 ml — AP FDA listed —
Sodium chloride 9 mg/mL 65219-0472-20 Fresenius 500 ml — AP FDA listed —
Sodium chloride 9 mg/mL 65219-0474-10 Fresenius 1000 ml — AP FDA listed —
Sodium chloride 9 mg/mL 17271-0701-02 Becton 50 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 00404-9955-10 Henry 1 vial — — FDA listed —
Sodium chloride 9 mg/mL 63323-0623-53 Fresenius 50 ml — AP FDA listed —
Sodium chloride 9 mg/mL 65219-0222-25 Fresenius 250 ml — AP FDA listed —
Sodium chloride 9 mg/mL 17271-0771-02 BECTON 50 ml — AP FDA listed —
Sodium chloride 9 mg/mL 65219-0224-50 Fresenius 500 ml — AP FDA listed —
Sodium chloride 9 mg/mL 65219-0218-50 Fresenius 50 ml — AP FDA listed —
Sodium chloride 9 mg/mL 65219-0220-10 Fresenius 100 ml — AP FDA listed —
Sodium chloride 9 mg/mL 65219-0282-10 Fresenius 1000 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 00487-4301-05 Nephron 50 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 55154-9357-05 Cardinal 5 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

🏛️
1978
On the market since
Feb 1978
📍
2026
Currently FDA-listed
48 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

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

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00264-1800-31, 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
47K
Units reimbursed last 4 qtrs
13.9M
Gross reimbursed last 4 qtrs
$7.06M
Avg / prescription
$150.26
Avg / unit
$0.5085
Latest quarter Q4 2025
9.9KRx
Fee-for-service vs managed care ⓘ
35% FFS 65% MCO
Fee-for-service · 16,321 Rx Managed care · 30,681 Rx
State Medicaid map
Alaska: no data reported AK Maine: 9,430 units · 676 per 100k residents ME Washington: no data reported WA Idaho: 14,000 units · 713 per 100k residents ID Montana: 12,868 units · 1,137 per 100k residents MT North Dakota: 3,095 units · 395 per 100k residents ND Minnesota: 298,856 units · 5,209 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 3,465,725 units · 17,708 per 100k residents NY Vermont: 3,000 units · 464 per 100k residents VT New Hampshire: 44,664 units · 3,186 per 100k residents NH Oregon: 1,015 units · 24.0 per 100k residents OR Nevada: 41,500 units · 1,299 per 100k residents NV Wyoming: no data reported WY South Dakota: 1,694 units · 184 per 100k residents SD Iowa: 202,550 units · 6,316 per 100k residents IA Illinois: 2,650 units · 21.1 per 100k residents IL Indiana: 41,900 units · 611 per 100k residents IN Ohio: 95,100 units · 807 per 100k residents OH Pennsylvania: 74,252 units · 573 per 100k residents PA New Jersey: 11,100 units · 119 per 100k residents NJ Massachusetts: 124,882 units · 1,784 per 100k residents MA California: 1,825,597 units · 4,685 per 100k residents CA Utah: no data reported UT Colorado: 11,750 units · 200 per 100k residents CO Nebraska: no data reported NE Missouri: 441,821 units · 7,131 per 100k residents MO Kentucky: 3,065,788 units · 67,737 per 100k residents KY West Virginia: no data reported WV Virginia: 98,698 units · 1,132 per 100k residents VA Maryland: 22,666 units · 367 per 100k residents MD Connecticut: 8,750 units · 242 per 100k residents CT Rhode Island: 20,500 units · 1,872 per 100k residents RI Arizona: no data reported AZ New Mexico: 135,426 units · 6,406 per 100k residents NM Kansas: 9,750 units · 332 per 100k residents KS Arkansas: 77,340 units · 2,522 per 100k residents AR Tennessee: 158,250 units · 2,221 per 100k residents TN North Carolina: 3,133,578 units · 28,921 per 100k residents NC South Carolina: 15,050 units · 280 per 100k residents SC Delaware: no data reported DE Oklahoma: 66,284 units · 1,635 per 100k residents OK Louisiana: no data reported LA Mississippi: 69,141 units · 2,352 per 100k residents MS Alabama: 30,489 units · 597 per 100k residents AL Georgia: no data reported GA D.C.: 43,000 units · 6,333 per 100k residents DC Hawaii: 20,518 units · 1,430 per 100k residents HI Texas: 134,191 units · 440 per 100k residents TX Florida: 53,430 units · 236 per 100k residents FL
Units reimbursed · per 100k residents
21.167,737
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 67,737 /100k
2 North Carolina 28,921 /100k
3 New York 17,708 /100k
4 Missouri 7,131 /100k
5 New Mexico 6,406 /100k
6 D.C. 6,333 /100k
7 Iowa 6,316 /100k
8 Minnesota 5,209 /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.
100 ml00264-1800-32 62,491 Rx · $7,309,583
50 ml this page00264-1800-31 46,443 Rx · $7,044,640
25 ml00264-1800-36 9,874 Rx · $2,674,523
Drug total (last 4 qtrs): 118,808 Rx · 49,255,545 units · $17,028,745 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 — the program that covers self-administered drugs. 9 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
$2.42M
Claims incl. refills
105K
Beneficiaries
50.3K
Spend / beneficiary
$48.15
Spend / claim
$23.08
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
00264-1800-31 You're viewing this 84 CONTAINER in 1 CASE (0264-1800-31) / 50 mL in 1 CONTAINER — — 1978-02-08 Active
00264-1800-32 64 CONTAINER in 1 CASE (0264-1800-32) / 100 mL in 1 CONTAINER $0.0262 / mL $167.87 1978-02-08 Active
00264-1800-36 116 CONTAINER in 1 CASE (0264-1800-36) / 25 mL in 1 CONTAINER — — 1978-02-08 Active

This pack accounts for about 39% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 00264-1800-31?
NDC 00264-1800-31 is listed by the FDA — 84 container in 1 case / 50 ml in 1 container.
What NDC number is used to bill for this package of Sodium Chloride 9 mg/mL Injection, Solution?
Bill NDC 00264-1800-31 — the 11-digit billing format is 00264180031. 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 0264-1800-31, 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: 00264-1800-31, written without dashes as 00264180031. 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 00264-1800-31, the first segment (00264) is the labeler code FDA assigned to B. Braun Medical Inc.; the middle segment (1800) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (31) 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 B. Braun Medical 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 ml (00264-1800-36), 100 ml (00264-1800-32). 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?
B. Braun Medical Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code A4216 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 60 words ▾

INDICATIONS AND USAGE This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. Consult prescribing information for INDICATIONS AND USAGE of drug additives to be administered in this manner.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION This solution is for intravenous use only. Do not use plastic container in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Use only if solution is clear and container and seals are intact.

As directed by a physician. Dosage is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations. There is no specific pediatric dose.

The dose is dependent on weight, clinical condition, and laboratory results. Follow recommendations of appropriate pediatric reference text. See PRECAUTIONS, Pediatric Use .

When using this product as a diluent or vehicle for administration of drug additives, consult the prescribing information of the drug to be used. Addition of medication should be accomplished using aseptic technique in order to assure sterility. Physicochemical studies have shown that the container and solution can withstand freezing.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques.

Mix thoroughly. Do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

⛔ Contraindications 16 words ▾

CONTRAINDICATIONS This solution is contraindicated where the administration of sodium or chloride could be clinically detrimental.

⚠️ Warnings 52 words ▾

WARNINGS Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.

🤒 Adverse Reactions 155 words ▾

ADVERSE REACTIONS Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia. The physician should also be alert to the possibility of adverse reactions to drug additives diluted and administered from the plastic partial fill container. Prescribing information for drug additives to be administered in this manner should be consulted.

Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential. Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

🔄 Drug Interactions 51 words ▾

Drug Interactions Sodium-containing solutions should be administered with caution to patients receiving cortiscosteroids or corticotrophin. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Studies have not been conducted to evaluate additional drug/drug or drug/food interactions with Sodium Chloride Injection USP.

🤰 Pregnancy 61 words ▾

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

🧒 Pediatric Use 53 words ▾

Pediatric Use Safety and effectiveness of sodium chloride injections in pediatric patients have not been established by adequate and well controlled trials, however, the use of Sodium Chloride solutions in the pediatric population is referenced in the medical literature. All Warnings, Precautions and Adverse Reactions described in this label apply to pediatric patients.

🧓 Geriatric Use 113 words ▾

Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🆘 Overdosage 22 words ▾

OVERDOSAGE In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition, and institute appropriate corrective treatment.

🧬 Clinical Pharmacology 101 words ▾

CLINICAL PHARMACOLOGY 0.9% Sodium Chloride Injection USP provides electrolytes and is a source of water for hydration. It is capable of inducing diuresis depending on the clinical condition of the patient. Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids.

Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid. Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

📦 How Supplied / Storage and Handling 98 words ▾

HOW SUPPLIED 0.9% Sodium Chloride Injection USP is supplied sterile and nonpyrogenic in partial fill polyolefin containers. The 100/150 mL product is packaged 64 per case. The 50/100 mL product is packaged 84 per case.

The 25/100 mL product is packaged 116 per case. NDC REF Fill/Container (mL) 0.9% Sodium Chloride Injection USP 0264-1800-36 S8004-5410 25/100 0264-1800-31 S8004-5384 50/100 0264-1800-32 S8004-5264 100/150 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.

It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

📋 Description 214 words ▾

DESCRIPTION Each mL of 0.9% Sodium Chloride Injection USP contains: Sodium Chloride USP 9 mg; Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.5 (4.5–7.0) Calculated Osmolarity: 310 mOsmol/liter Concentration of Electrolytes (mEq/100 mL): Sodium

15.4 Chloride

15.4This solution is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Sodium Chloride USP NaCl

58.44Not made with natural rubber latex, PVC or DEHP. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability.

The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers.

These tests have shown that the container is nontoxic and biologically inert. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition site.

Each is covered by a tamperproof barrier. Refer to the Directions for Use of the container to properly identify the ports. No vapor barrier is necessary.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00264-1510-31 · B. 00264-1933-10 · B. →
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.