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Sodium Chloride 900 mg/100mL Injection — NDC 49230-0300-10 package photo

Sodium Chloride 900 mg/100mL Injection

by Fresenius Medical Care Renal Therapies Group, LLC · 12 BAG in 1 CARTON (49230-300-10) / 1000 mL in 1 BAG
NDC 49230-0300-10
🏷️ FDA NDC (as labeled) 49230-300-10 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Aug 6, 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 · May 27, 2025 — Lack of Assurance of Sterility (Fresenius Medical Care Holdings, Inc.) · FDA recall D-0490-2025
Class II · Nov 22, 2022 — Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution. (Fresenius Medical Care Holdings, Inc.) · FDA recall D-0075-2023
Class II · Oct 11, 2022 — Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution. (Fresenius Medical Care Holdings, Inc.) · FDA recall D-0015-2023
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 ↗
Past resolved recalls for this product (1)
Class II · May 23, 2023 · Terminated — Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. (Fresenius Medical Care Holdings, Inc.) · FDA recall D-0777-2023

🆔 Identity & classification

FDA NDC (as labeled) 49230-300-10
Product NDC 49230-300
11-digit billing NDC 49230030010
NCPDP billing unit ML — per mL (volume)
RxCUI 1807639
UNII 451W47IQ8X
Application # ANDA078177
SPL Set ID af5cdf1a-19f4-11e2-892e-0800200c9a66
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 ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-04-12
Route INTRAVENOUS
Dosage form INJECTION
Substance 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 49230-300-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 49230-0300-10. 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

LabelerFresenius Medical Care Renal Therapies Group, LLC
Application holderFRESENIUS MEDICAL CARE NORTH AMERICA
FDA applicationANDA078177 (ANDA)
Labeler code49230
First marketedApr 2007
Product typeHuman Prescription Drug
Portfolio7 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 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.

1 inactive ingredient 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 $0.0504 $0.60 / 12 bags
Medicare drug plans payPart D · Q2 2026 $0.0121 $0.15 / 12 bags
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Chloride 900 mg/100mL 00409-7101-02 Hospira, 24 pouches $0.021 AP Availability likely —
Sodium Chloride .9 g/100mL 00264-5802-00 B. 1000 ml — AP FDA listed —
Sodium Chloride .9 g/100mL 00264-7800-09 B. 1000 ml — AP FDA listed —
Sodium Chloride 9 g/1000mL 00338-0049-01 Baxter 150 ml — — Discontinued —
Sodium Chloride 9 g/1000mL 00338-9543-01 Baxter 250 ml — — FDA listed —
Sodium Chloride 9 g/1000mL 00338-9793-12 Baxter 1000 ml — — FDA listed —
Sodium Chloride 9 g/1000mL 00338-9806-12 Baxter 1000 ml — — FDA listed —
Sodium Chloride 900 mg/100mL 00990-7983-02 ICU 24 pouches — AP FDA listed —
Sodium chloride 9 mg/mL 17271-0701-02 Becton 50 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 46163-0300-10 Fresenius 1000 ml — AP FDA listed —
Sodium Chloride 900 mg/100mLthis 49230-0300-10 Fresenius 1000 ml — AP FDA listed —
0.9% Sodium Chloride 900 mg/100mL 51662-1518-01 HF 1 pouch — AP FDA listed —
Sodium chloride 9 mg/mL 63323-0623-53 Fresenius 50 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 63323-0632-40 Fresenius 1000 ml — AP FDA listed —
Sodium chloride 9 mg/mL 65219-0282-10 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 65219-0474-10 Fresenius 1000 ml — AP FDA listed —
Sodium Chloride 9 g/1000mL 70512-0841-06 SOLA 50 ml — AP FDA listed —
Sodium Chloride 9 g/1000mL 76297-0001-01 LABORATORIOS 500 ml — AP FDA listed —
Sodium Chloride 9 g/1000mL 79672-0613-10 Nextgen 50 ml — AP FDA listed —
Sodium Chloride 9 g/1000mL 81826-0001-01 CODAN 50 ml — AP FDA listed —
Polifleks .9 g/100mL 84879-0263-01 POLIFARMA 50 ml — — Discontinued —
Isotonic Sodium Chloride .9 g/100mL 85184-0001-01 HAVER 100 ml — — Discontinued —
Sodium Chloride 9 g/1000mL 85766-0059-00 Sportpharm 1000 ml — — FDA listed —
Sodium Chloride 900 mg/100mL 51662-1522-01 HF 500 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-0186-04 Baxter 100 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-0162-01 Baxter 100 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00990-7984-13 ICU 48 pouches — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-0196-04 Baxter 100 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-9159-30 Baxter 100 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-0166-01 Baxter 100 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-9662-35 Baxter 100 ml — AP FDA listed —
Sodium Chloride 900 mg/100mL 00338-0553-11 Baxter 50 ml — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2007
On the market since
Apr 2007
📍
2026
Currently FDA-listed
19 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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

🗺️ 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 49230-0300-10, 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
20.9K
Units reimbursed last 4 qtrs
23.9M
Gross reimbursed last 4 qtrs
$1.2M
Avg / prescription
$57.58
Avg / unit
$0.0504
Latest quarter Q4 2025
9.1KRx
Fee-for-service vs managed care ⓘ
26% FFS 74% MCO
Fee-for-service · 5,424 Rx Managed care · 15,485 Rx
State Medicaid map
Alaska: 319,865 units · 43,638 per 100k residents AK Maine: no data reported ME Washington: no data reported WA Idaho: 2,343,000 units · 119,297 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 1,384,000 units · 7,072 per 100k residents NY Vermont: no data reported VT New Hampshire: 258,000 units · 18,402 per 100k residents NH Oregon: no data reported OR Nevada: 806,000 units · 25,235 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 281,000 units · 4,095 per 100k residents IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: 188 units · 2.7 per 100k residents MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 339,000 units · 17,139 per 100k residents NE Missouri: 3,086,000 units · 49,806 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 2,467,000 units · 28,304 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 655,000 units · 9,192 per 100k residents TN North Carolina: no data reported NC South Carolina: 104,320 units · 1,942 per 100k residents SC Delaware: no data reported DE Oklahoma: 81,000 units · 1,999 per 100k residents OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 54 units · 1.1 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 11,783,000 units · 52,114 per 100k residents FL
Units reimbursed · per 100k residents
1.1119,297
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 119,297 /100k
2 Florida 52,114 /100k
3 Missouri 49,806 /100k
4 Alaska 43,638 /100k
5 Virginia 28,304 /100k
6 Nevada 25,235 /100k
7 New Hampshire 18,402 /100k
8 Nebraska 17,139 /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.

📊 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
49230-0300-10 You're viewing this 12 BAG in 1 CARTON (49230-300-10) / 1000 mL in 1 BAG 2007-04-12 Active

🧭 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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 49230-300-10, 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: 49230-0300-10, written without dashes as 49230030010. 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 49230-0300-10, the first segment (49230) is the labeler code FDA assigned to Fresenius Medical Care Renal Therapies Group, LLC; the middle segment (0300) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 Fresenius Medical Care Renal Therapies Group, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Fresenius Medical Care Renal Therapies Group, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 27 words ▾

INDICATIONS AND USAGE Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION The dose is dependent upon the age, weight and clinical condition of the patient. Additives may be incompatible. Consult with pharmacist, if available.

When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS .) INSTRUCTIONS FOR USE To Open Tear outer wrap at notch and remove solution container.

If supplemental medication is desired, follow directions below before preparing for administration. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety.

The opacity will diminish gradually. To Add Medication Prepare additive port. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject.

Withdraw needle after injecting medication. The additive port may be protected by covering with an additive cap. Mix container contents thoroughly.

Preparation for Administration (Use Aseptic Technique) Close flow control clamp of administration set. Remove cover from outlet port at bottom of container. Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated.

NOTE: See full directions on administration set carton. Suspend container from hanger. Squeeze and release drip chamber to establish proper fluid level in chamber.

Open flow control clamp and clear air from set. Close clamp. Attach set to venipuncture device.

If device is not indwelling, prime and make venipuncture. Regulate rate of administration with flow control clamp. WARNING: Do not use flexible container in series connections. sodium-chloride-injection-1

⛔ Contraindications 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings 120 words ▾

WARNINGS 0.9% Sodium Chloride Injection, USP 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 exists edema with sodium retention. The intravenous administration of 0.9% Sodium Chloride Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutive states is inversely proportional to the electrolyte concentration of the injections.

The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections. In patients with diminished renal function, administration of 0.9% Sodium Chloride Injection, USP may result in sodium retention.

🤒 Adverse Reactions 66 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. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic counter measures and save the remainder of the fluid for examination if deemed necessary.

🆘 Overdosage 26 words ▾

OVERDOSAGE In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. (See WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS .)

🧬 Clinical Pharmacology 216 words ▾

CLINICAL PHARMACOLOGY When administered intravenously, this solution provides a source of water and electrolytes. Solutions which provide combinations of hypotonic or isotonic concentrations of sodium chloride are suitable for parenteral maintenance or replacement of water and electrolyte requirements. Isotonic concentrations of sodium chloride are suitable for parenteral replacement of chloride losses that exceed or equal the sodium loss.

Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl-) ions. Sodium (Na+) is the principle cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl-) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells.

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. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements range 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 57 words ▾

HOW SUPPLIED 0.9% Sodium Chloride Injection, USP is supplied in a 1000 mL single-dose flexible plastic container. (US manufactured NDC number 49230-300-10) (Mexico manufactured DNC number 46163-300-10) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Fresenius Medical Care Renal Therapies Group, LLC Lawrence, MA 01843 1-800-323-5188 89-900-74 Rev. 03/15

📋 Description ~1 min read ▾

DESCRIPTION 0.9% Sodium Chloride Injection, USP is sterile and nonpyrogenic. It is a parenteral solution containing 0.9% sodium chloride in water for injection intended for intravenous administration. Each 100 mL of 0.9% Sodium Chloride Injection, USP contains 900 mg sodium chloride in water for injection.

Electrolytes per 1000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH is 5.6.

The pH range is 4.5 - 7.0. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded.

The solution is a parenteral fluid and electrolyte replenisher. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designed H 2 O.

The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 49230-0212-23 · Fresenius 49230-0530-10 · Fresenius →
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.