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Sodium Chloride .9 g/100mL Irrigant — NDC 00264-2201-00 package photo

Sodium Chloride .9 g/100mL Irrigant

by B. Braun Medical Inc. · 16 CONTAINER in 1 CASE (0264-2201-00) / 1000 mL in 1 CONTAINER
NDC 00264-2201-00
🏷️ FDA NDC (as labeled) 0264-2201-00 billing pads the labeler segment with a zero
This package
Contains1000 mL in 1 container Medicaid pays$0.0058 / unit · 12 mo Per package$0.09 / 16 containers · Medicaid Pack sizes4 compare ↓
Also priced by: Part D plans $0.0100/unit — full pricing hub ↓
Also comes in: 500 ml 00264-2201-10 2000 ml 00264-2201-50 4000 ml 00264-2201-70
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

🚨
Active recall for this product.
Class II · Mar 31, 2025 — Presence of Particulate Matter (B. Braun Medical Inc) · FDA recall D-0353-2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
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) 0264-2201-00
Product NDC 0264-2201
11-digit billing NDC 00264220100
NCPDP billing unit ML — per mL (volume)
RxCUI 486515
UNII 451W47IQ8X
Application # NDA016733
SPL Set ID 0d59a04a-32e6-485b-b638-a1e6c09e9642
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 2009-09-14
Route IRRIGATION
Dosage form IRRIGANT
Substance SODIUM CHLORIDE
GPI-14 56700060002010
GPI class Sodium Chloride
GCN Seq No 009827
GCN 45360
HICL code 004285
Ingredient (HICL) Sodium Chloride Irrig Solution
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W8
Therapeutic class — intermediate (HIC2) Antiseptics
HIC3 code W8F
Therapeutic class — specific (HIC3) Irrigants
AHFS code 40:36.00.00
AHFS class Irrigating Solutions
FDB label name SODIUM CHLORIDE 0.9% IRRIG.
FDB brand name Sodium Chloride
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 0264-2201-00 — 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 → 00264-2201-00. 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 applicationNDA016733 (NDA)
Labeler code00264
First marketedSep 2009
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% IRRIG. Ingredient Sodium Chloride Irrig Solution
📗 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.0058 $0.09 / 16 containers
Medicare drug plans payPart D · Q2 2026 $0.0100 $0.16 / 16 containers
Medicare Part B allowsASP · A4217 No ASP payment limit on file for A4217 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)0264-2201-00
11-digit billing NDC00264-2201-00
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeA4217
DescriptorSTERILE WATER/SALINE, 500 ML
Billing units / pkg0 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 g/100mLthis 00264-2201-00 B. 1000 ml — AT FDA listed —
Sodium Chloride for Irrigation .9 g/100mL 00264-7388-50 B. 2000 ml — AT FDA listed —
Sodium Chloride 900 mg/100mL 00338-0047-44 Baxter 1000 ml — AT FDA listed —
Sodium Chloride 900 mg/100mL 00338-0048-02 Baxter 24 bottles — AT FDA listed —
Sodium Chloride 900 mg/100mL 00338-0050-47 Baxter 3000 ml — AT FDA listed —
Sodium Chloride 9 g/1000mL 00338-0051-44 Baxter 1000 ml — — FDA listed —
Sodium Chloride 900 mg/100mL 00338-0110-04 Baxter 3000 ml — — FDA listed —
Sodium Chloride 900 mg/100mL 00338-9834-04 Baxter 3000 ml — — FDA listed —
Sodium Chloride 900 mg/100mL 00990-7972-05 ICU 1000 ml — AT FDA listed —
Sodium chloride .9 g/100mL 17271-0800-07 Becton 1000 ml — AT FDA listed —
Sodium chloride .9 g/100mL 65219-0502-10 Fresenius 1000 ml — AT FDA listed —
Sodium chloride .9 g/100mL 65219-0504-20 Fresenius 2000 ml — AT FDA listed —
Sodium chloride .9 g/100mL 65219-0506-30 Fresenius 3000 ml — AT 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

🏛️
2009
On the market since
Sep 2009
📍
2026
Currently FDA-listed
17 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 00264-2201-00, 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
9.5K
Units reimbursed last 4 qtrs
66.2M
Gross reimbursed last 4 qtrs
$383.5K
Avg / prescription
$40.58
Avg / unit
$0.0058
Latest quarter Q4 2025
2.3KRx
Fee-for-service vs managed care ⓘ
67% FFS 33% MCO
Fee-for-service · 6,321 Rx Managed care · 3,130 Rx
State Medicaid map
Alaska: no data reported AK Maine: 188,000 units · 13,477 per 100k residents ME Washington: 1,253,838 units · 16,050 per 100k residents WA Idaho: 14,426,000 units · 734,521 per 100k residents ID Montana: 879,335 units · 77,680 per 100k residents MT North Dakota: no data reported ND Minnesota: 624,003 units · 10,877 per 100k residents MN Wisconsin: 994,498 units · 16,827 per 100k residents WI Michigan: 431,325 units · 4,297 per 100k residents MI New York: 3,571,839 units · 18,251 per 100k residents NY Vermont: no data reported VT New Hampshire: 168,127 units · 11,992 per 100k residents NH Oregon: 6,090,000 units · 143,870 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 11,020,000 units · 343,623 per 100k residents IA Illinois: 956,800 units · 7,625 per 100k residents IL Indiana: 871,994 units · 12,708 per 100k residents IN Ohio: 2,032,790 units · 17,249 per 100k residents OH Pennsylvania: 613,300 units · 4,732 per 100k residents PA New Jersey: 155,236 units · 1,671 per 100k residents NJ Massachusetts: no data reported MA California: 14,418,659 units · 37,004 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 668,125 units · 10,783 per 100k residents MO Kentucky: 405,751 units · 8,965 per 100k residents KY West Virginia: 145,000 units · 8,192 per 100k residents WV Virginia: 514,739 units · 5,906 per 100k residents VA Maryland: no data reported MD Connecticut: 115,000 units · 3,179 per 100k residents CT Rhode Island: no data reported RI Arizona: 116,760 units · 1,571 per 100k residents AZ New Mexico: no data reported NM Kansas: 90,545 units · 3,080 per 100k residents KS Arkansas: 245,136 units · 7,993 per 100k residents AR Tennessee: 819,532 units · 11,501 per 100k residents TN North Carolina: 433,000 units · 3,996 per 100k residents NC South Carolina: 524,850 units · 9,768 per 100k residents SC Delaware: no data reported DE Oklahoma: 201,800 units · 4,979 per 100k residents OK Louisiana: no data reported LA Mississippi: 832,001 units · 28,299 per 100k residents MS Alabama: no data reported AL Georgia: 360,101 units · 3,265 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 1,329,603 units · 4,359 per 100k residents TX Florida: 670,585 units · 2,966 per 100k residents FL
Units reimbursed · per 100k residents
1,571734,521
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 Idaho 734,521 /100k
2 Iowa 343,623 /100k
3 Oregon 143,870 /100k
4 Montana 77,680 /100k
5 California 37,004 /100k
6 Mississippi 28,299 /100k
7 New York 18,251 /100k
8 Ohio 17,249 /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.
1 ml this page00264-2201-00 9,451 Rx · $383,494
5 ml00264-2201-10 3,787 Rx · $141,393
2 ml00264-2201-50 No Medicaid data
4 ml00264-2201-70 No Medicaid data
Drug total (last 4 qtrs): 13,238 Rx · 78,510,845 units · $524,887 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 Marketing startStatus
00264-2201-00 You're viewing this 16 CONTAINER in 1 CASE (0264-2201-00) / 1000 mL in 1 CONTAINER 2009-09-14 Active
00264-2201-10 16 CONTAINER in 1 CASE (0264-2201-10) / 500 mL in 1 CONTAINER 2009-09-14 Active
00264-2201-50 8 CONTAINER in 1 CASE (0264-2201-50) / 2000 mL in 1 CONTAINER 2009-09-14 Discontinued by firm
00264-2201-70 4 CONTAINER in 1 CASE (0264-2201-70) / 4000 mL in 1 CONTAINER 2009-09-14 Discontinued by firm

In Medicaid, this is the most-dispensed pack of this product — about 71% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00264-2201-00?
NDC 00264-2201-00 is listed by the FDA — 16 container in 1 case / 1000 ml in 1 container.
What NDC number is used to bill for this package of Sodium Chloride .9 g/100mL Irrigant?
Bill NDC 00264-2201-00 — the 11-digit billing format is 00264220100. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 0264-2201-00, 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: 00264-2201-00, written without dashes as 00264220100. 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 00264-2201-00, the first segment (00264) is the labeler code FDA assigned to B. Braun Medical Inc.; the middle segment (2201) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 3 other package presentations of this same product, including 500 ml (00264-2201-10), 2000 ml (00264-2201-50), 4000 ml (00264-2201-70). 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 A4217 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 28 words ▾

INDICATIONS AND USAGE 0.9% Sodium Chloride Irrigation USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

⏱️ Dosage and Administration 61 words ▾

DOSAGE AND ADMINISTRATION As required for irrigation. When used as a diluent, or vehicle for other drugs, the drug manufacturer’s recommendations should be followed. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.

⛔ Contraindications 26 words ▾

CONTRAINDICATIONS 0.9% Sodium Chloride Irrigation USP is not for injection by usual parenteral routes. An electrolyte solution should not be used for irrigation during electrosurgical procedures.

⚠️ Warnings 126 words ▾

WARNINGS FOR IRRIGATION ONLY. NOT FOR INJECTION. Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs.

Absorption of large amounts can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

Do not warm above 150°F (66°C). After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard unused portion of irrigating solution since it contains no preservatives.

🤒 Adverse Reactions 97 words ▾

ADVERSE REACTIONS Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues.

Accidental contamination from careless technique may transmit infection. If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

🔄 Drug Interactions 21 words ▾

Drug Interactions Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic technique. Mix thoroughly. Do not store.

🤰 Pregnancy 59 words ▾

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

🧒 Pediatric Use 37 words ▾

Pediatric Use The safety and effectiveness of 0.9% Sodium Chloride Irrigation USP in pediatric patients have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

🧓 Geriatric Use 147 words ▾

Geriatric Use Clinical studies of 0.9% Sodium Chloride Irrigation USP did not include a sufficient number of patients age 65 years and over to determine whether they respond differently from younger subjects. 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 to this drug 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. Frequent laboratory determinations and clinical evaluations are recommended to monitor changes in blood glucose, electrolyte concentrations, and renal function.

🆘 Overdosage 34 words ▾

OVERDOSAGE In the event of overhydration or solute overload, reevaluate the patient’s condition, and institute appropriate corrective treatment. Intravascular volume overload may respond to hemodialysis. See WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS .

🧬 Clinical Pharmacology 163 words ▾

CLINICAL PHARMACOLOGY 0.9% Sodium Chloride Irrigation USP is utilized for a variety of clinical indications such as sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters, surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations. 0.9% Sodium Chloride Irrigation USP provides an isotonic saline irrigation identical in composition with 0.9% Sodium Chloride Injection USP (normal saline).

Physiological irrigation solutions are considered generally compatible with living tissues and organs. 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 114 words ▾

HOW SUPPLIED 0.9% Sodium Chloride Irrigation USP is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation Container). The 1000 mL and 500 mL containers are packaged 16 per case. NDC Cat.

No. Size 0.9% Sodium Chloride Irrigation USP 0264-2201-00 R5200-01 1000 mL 0264-2201-10 R5201-01 500 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.

Protect from freezing. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] However, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).

Bottle may exhibit some discoloration upon storage which does not impact product quality.

📋 Description 181 words ▾

DESCRIPTION Each 100 mL contains: Sodium Chloride USP 0.9 g; Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.0 (4.5–7.0) Calculated Osmolarity: 310 mOsmol/liter Concentration of Electrolytes (mEq/liter): Sodium 154; Chloride 154 0.9% Sodium Chloride Irrigation USP 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

58.44The 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 plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration.

The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl 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. Not made with natural rubber latex, PVC or DEHP. Bottle may exhibit some discoloration upon storage which does not impact product quality.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00264-2101-00 · B. 00264-2202-00 · 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.