NDC 65219-0475-30 — LACTATED RINGERS SODIUM CHLORIDE, SODIUM

🆔 Identity & classification

FDA NDC (as labeled) 65219-475-30

Product NDC 65219-475

11-digit billing NDC 65219047530

NCPDP billing unit ML — per mL (volume)

RxCUI 847630

UNII 451W47IQ8X, M4I0D6VV5M, 660YQ98I10, TU7HW0W0QT

Application # ANDA209338

SPL Set ID 8fce1477-991f-4b43-bf05-a80bad897262

Established class (EPC) Blood Coagulation Factor; Cations; Inhibition Larg

Physiologic effect Increased Coagulation Factor Activity; Increased Large Intestinal Motility

Chemical class Calcium; Divalent

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2019-01-28

Route INTRAVENOUS

Dosage form INJECTION, SOLUTION

Substance SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE

GPI-14 79992001202010

GCN Seq No 001187

GCN 02840

HICL code 000525

Ingredient (HICL) Ringer's Solution,Lactated

HIC1 code C

Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition

HIC2 code C1

Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance

HIC3 code C1W

Therapeutic class — specific (HIC3) Electrolyte Maintenance

AHFS code 40:12.00.00

AHFS class Replacement Preparations

FDB label name LACTATED RINGERS INJECTION

FDB brand name Lactated Ringers

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 65219-475-30 — 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 → 65219-0475-30. 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 Organic acids class.

Drug family (ATC) Organic acids

How it works Acidifying Activity

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 Kabi USA, LLC

Application holderFRESENIUS KABI USA LLC

FDA applicationANDA209338 (ANDA)

Labeler code65219

First marketedJan 2019

Product typeHuman Prescription Drug

Portfolio554 products on file

🔎 All NDCs from Fresenius Kabi USA, LLC

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 LACTATED RINGERS INJECTION Ingredient Ringer's Solution,Lactated

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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 system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J7120	$2.313 / J7120 unit	—

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)65219-475-30

11-digit billing NDC65219-0475-30

Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)

HCPCS J-codeJ7120

DescriptorRINGERS LACTATE INFUSION, UP TO 1000 CC

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Lactated Ringers .6 g/100mL; .31 g/100mL; .03 g/100mL; .02 g/100mL 00264-7750-00	B.	1000 ml	$0.004	AP	Availability likely	—
Lactated Ringers 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL 00338-0117-02	Baxter	250 ml	—	AP	FDA listed	—
Lactated Ringers 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL 00990-7953-02	ICU	24 pouches	—	AP	FDA listed	—
Lactated Ringers 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL 17271-0710-05	Becton	250 ml	—	AP	FDA listed	—
Lactated Ringers 600 mg/100mL; 310 mg/100mL; 20 mg/100mL; 30 mg/100mL 51662-1516-01	HF	1 pouch	—	AP	FDA listed	—
Lactated Ringers 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL 63323-0164-74	Fresenius	250 ml	—	AP	FDA listed	—
Lactated Ringers 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mLthis 65219-0475-30	Fresenius	250 ml	—	AP	FDA listed	—
Lactated Ringers 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL 65219-0477-20	Fresenius	500 ml	—	AP	FDA listed	—
Lactated Ringers 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL 65219-0479-10	Fresenius	1000 ml	—	AP	FDA listed	—
Lactated Ringers 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL 76420-0129-01	Asclemed	1000 ml	—	AP	FDA listed	—
Lactated Ringers .6 g/100mL; .31 g/100mL; .03 g/100mL; .02 g/100mL 76420-0274-01	Asclemed	1000 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

🏛️

2019

On the market since

Jan 2019

📍

2026

Currently FDA-listed

7 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.

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

Medicare Part D (outpatient prescription) spending for Lactated Ringers — the program that covers self-administered drugs. 4 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 Lactated Ringers. 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

$171.8K

Claims incl. refills

6.2K

Beneficiaries

1.9K

Spend / beneficiary

$89.88

Spend / claim

$27.60

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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Lactated Ringers (this brand).

Top reported reactions

Acute Kidney Injury63

Dyspnoea62

Tachycardia53

Blindness50

Hypotension47

Pruritus43

Pain38

Age at onset

Neonate5

Infant55

Child13

Adolescent6

Adult81

Elderly10

Reporter sex

Male · 38%

Female · 62%

Unknown · 1%

Serious outcomes

Hospitalization298

Life-threatening117

Death111

Disabling22

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
65219-0475-30 You're viewing this	30 BAG in 1 CASE (65219-475-30) / 250 mL in 1 BAG (65219-475-05)	2019-01-28	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	✓ Available
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

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 65219-475-30, 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: 65219-0475-30, written without dashes as 65219047530. 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 65219-0475-30, the first segment (65219) is the labeler code FDA assigned to Fresenius Kabi USA, LLC; the middle segment (0475) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Fresenius Kabi USA, 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.

Does this product have a billing J-code?

Yes — this NDC cross-references HCPCS code J7120 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 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description

🎯 Indications and Usage 20 words ▾

INDICATIONS AND USAGE: Lactated Ringer's Injection is indicated as a source of water and electrolytes or as an alkalinizing agent.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION: As directed by a physician. Dosage, rate and duration of administration are to be individualized and dependent upon the indication for use, the patient's age, weight, concomitant treatment and clinical condition of the patient as well as laboratory determinations. All injections in flexible plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment.

After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. Do not reconnect any partially used containers. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Do not administer unless the solution is clear and seal is intact. When making additions to Lactated Ringer's Injection, aseptic technique must be used. Mix the solution thoroughly when additives have been introduced.

Do not store solutions containing additives. Additives may be incompatible with Lactated Ringer's Injection. As with all parenteral solutions, compatibility of the additives with the solution must be assessed before addition, by checking for a possible color change and/or the appearance of precipitates, insoluble complexes, or crystals.

Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Lactated Ringer's Injection is appropriate. The instructions for use of the medication to be added and other relevant literature must be consulted. Additives known or determined to be incompatible should not be used.

⛔ Contraindications 107 words ▾

CONTRAINDICATIONS: As for other calcium-containing infusion solutions, concomitant administration of ceftriaxone and Lactated Ringer's Injection is contraindicated in newborns (≤ 28 days of age), even if separate infusion lines are used (risk of fatal ceftriaxone-calcium salt precipitation in the neonate's bloodstream). In patients older than 28 days (including adults), ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions, including Lactated Ringer's Injection, through the same infusion line (e.g., via Y-connector).

If the same infusion line is used for sequential administration, the line must be thoroughly flushed between infusions with a compatible fluid. Lactated Ringer's Injection is contraindicated in patients with a known hypersensitivity to sodium lactate.

⚠️ Warnings ~2 min read ▾

WARNINGS: Although Lactated Ringer's Injection has a potassium concentration similar to the concentration in plasma, it is insufficient to produce a useful effect in case of severe potassium deficiency; therefore, it should not be used for this purpose. Lactated Ringer's Injection is not for use for the treatment of lactic acidosis or severe metabolic acidosis. Lactated Ringer's Injection should not be administered simultaneously with citrate anticoagulated/preserved blood through the same administration set because of the likelihood of coagulation.

The infusion must be stopped immediately if any signs or symptoms of a suspected hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Hypersensitivity reactions are reported more frequently during pregnancy.

Depending on the volume and the rate of infusion, the intravenous administration of Lactated Ringer's Injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, pulmonary edema or acid-base imbalance. The risk of dilutional states is inversely proportional to the electrolyte concentrations 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.

Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation. Lactated Ringer's Injection should be administered with particular caution, if at all, to patients with hyperkalemia or conditions predisposing to hyperkalemia (such as severe renal impairment or adrenocortical insufficiency, acute dehydration, or extensive tissue injury or burns) and in patients with cardiac disease.

Lactated Ringer's Injection should be administered with particular caution, if at all, to patients with alkalosis or at risk for alkalosis. Because lactate is metabolized to bicarbonate, administration may result in, or worsen, metabolic alkalosis. Lactated Ringer's Injection should be administered with particular caution, if at all, to patients with severe renal impairment, hypervolemia, overhydration, or conditions that may cause sodium and/or potassium retention, fluid overload, or edema.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS: Post-Marketing Adverse Reactions The following adverse reactions have been reported in the post-marketing experience, listed by MedDRA System Organ Class (SOC). Immune System Disorders Hypersensitivity/infusion reactions, including anaphylactic/anaphylactoid reactions, and the following manifestations: angioedema, chest pain, chest discomfort, decreased heart rate, tachycardia, blood pressure decreased, respiratory distress, bronchospasm, dyspnea, cough, urticaria, rash, pruritus, erythema, flushing, throat irritation, paresthesia, hypoesthesia oral, dysgeusia, nausea, anxiety, pyrexia, headache.

Metabolism and Nutrition Disorders Hyperkalemia. General Disorders and Administration Site Conditions Infusion site reactions, including phlebitis, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pruritus, infusion site erythema, infusion site pain, infusion site burning. Class Reactions Hypersensitivity reactions, including, laryngeal edema and sneezing Hypervolemia Infusion site reactions, including infection at the site of injection, extravasation, and infusion site anesthesia (numbness) Overdose An excessive volume or too high a rate of administration of Lactated Ringer's Injection may lead to fluid and sodium overload with a risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired.

Excessive administration of lactate may lead to metabolic alkalosis. Metabolic alkalosis may be accompanied by hypokalemia. Excessive administration of potassium may lead to the development of hyperkalemia, especially in patients with severe renal impairment.

Excessive administration of calcium salts may lead to hypercalcemia. When assessing an overdose, any additives in the solution must also be considered. The effects of an overdose may require immediate medical attention and treatment.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 200 words ▾

Drug Interactions Ceftriaxone (see CONTRAINDICATIONS ). Caution is advised when administering Lactated Ringer's Injection to patients treated with drugs that may increase the risk of sodium and fluid retention, such as corticosteroids. Caution is advised when administering Lactated Ringer's Injection to patients treated with drugs for which renal elimination is pH dependent.

Due to the alkalinizing action of lactate (formation of bicarbonate), Lactated Ringer's Injection may interfere with the elimination of such drugs. Renal clearance of acidic drugs such as salicylates and barbiturates may be increased. Renal clearance of alkaline drugs, such as sympathomimetics (e.g., ephedrine, pseudoephedrine) and dextroamphetamine (dexamphetamine) sulfate, may be decreased.

Renal clearance of lithium may also be increased. Caution is advised when administering Lactated Ringer's Injection to patients treated with lithium. Because of its potassium content, Lactated Ringer's Injection should be administered with caution in patients treated with agents or products that can cause hyperkalemia or increase risk of hyperkalemia, such as potassium sparing diuretics (amiloride, spironolactone, triamterene), with ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine.

Caution is advised when administering Lactated Ringer's Injection to patients treated with thiazide diuretics or vitamin D, as these can increase the risk of hypercalcemia.

🤰 Pregnancy 63 words ▾

Pregnancy Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with Lactated Ringer's Injection. It is also not known whether Lactated Ringer's Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Lactated Ringer's Injection should be given to a pregnant woman only if clearly needed. For Hypersensitivity Reactions During Pregnancy (see WARNINGS ).

🧒 Pediatric Use 74 words ▾

Pediatric Use Safety and effectiveness of Lactated Ringer's Injection in pediatric patients have not been established by adequate and well controlled trials, however, the use of electrolyte solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population. Lactate-containing solutions should be administered with particular caution to neonates and infants less than 6 months of age.

🧓 Geriatric Use 84 words ▾

Geriatric Use Clinical studies of Lactated Ringer's Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the 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.

🧬 Clinical Pharmacology 53 words ▾

CLINICAL PHARMACOLOGY: Lactated Ringer's Injection has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient. Lactated Ringer's Injection produces a metabolic alkalinizing effect. Lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

📦 How Supplied / Storage and Handling 128 words ▾

HOW SUPPLIED: Lactated Ringer's Injection, USP in a single dose flexible plastic container, is available as follows: Product Code Each Unit of Sale 417730 NDC 65219-475-05 One 250 mL free flex ® Bag NDC 65219-475-30 Sold in units of 30 417720 NDC 65219-477-05 One 500 mL free flex ® Bag NDC 65219-477-20 Sold in units of 20 417710 NDC 65219-479-05 One 1,000 mL free flex ® Bag NDC 65219-479-10 Sold in units of 10 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. STORE AT: 20 ° to 25 °C ( 68 ° to 77 °F) [see USP Controlled Room Temperature]; brief exposure up to 40°C does not adversely affect the product.

The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

📦 Storage and Handling 42 words ▾

STORE AT: 20 ° to 25 °C ( 68 ° to 77 °F) [see USP Controlled Room Temperature]; brief exposure up to 40°C does not adversely affect the product. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

📋 Description 197 words ▾

DESCRIPTION: Lactated Ringer's Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1 .

Table 1 Size (mL) Composition (g/L) Ionic Composition (mEq/L) Caloric Content (kcal/L) Sodium Chloride, USP (NaCl) Sodium Lactate, USP (C 3 H 5 NaO 3 ) Potassium Chloride, USP (KCl) Calcium Chloride, USP (CaCl 2 •2H 2 O) Osmolarity (mOsmol/L) (calc) pH Sodium Potassium Calcium Chloride Lactate Lactated Ringer's Injection, USP 250 6 3.1 0.3 0.2 273 6.5 (6.0 to 7.5) 130 4 2.7 109 28 9 500 1,000 The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag).

The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dysgeusia: A changed or unpleasant sense of taste, such as a metallic taste.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

edema: Swelling caused by extra fluid trapped in the body's tissues.

electrolyte: A mineral in the blood and body fluids, such as sodium, potassium, or calcium, that carries a small electric charge and helps the body work.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

extravasation: The accidental leaking of an injected medicine out of the vein into the surrounding tissue, which can cause pain, swelling, or tissue damage.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

hypercalcemia: A higher-than-normal level of calcium, a mineral, in the blood.

hyperkalemia: A higher-than-normal level of potassium, an important mineral, in the blood.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypoesthesia: A reduced sense of touch or feeling in part of the body, so it feels partly numb.

hypokalemia: A lower-than-normal level of potassium, an important mineral, in the blood.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

lactic acidosis: A buildup of a waste product called lactic acid in the blood, which makes the blood too acidic.

metabolic acidosis: A condition where too much acid builds up in the body's blood and fluids.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

pruritus: Itching of the skin.

pulmonary edema: A buildup of fluid in the lungs' air sacs that makes it hard to breathe.

pyrexia: A raised body temperature; a fever.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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Electrolyte-S Solution 00264-7703-00 Electrolyte-S (Ph 7.4) 00264-7707-00 Electrolyte-P Solution/D5W 00264-7730-10 Ringer's Solution 00264-7780-00 Electrolyte-48 Solution/D5W 00338-0143-03 Electrolyte-148 Solution 00338-0179-03 Electrolyte-A Solution 00338-0221-03 Electrolyte-148 (Ph 7.4) 00338-9593-10 Sodium/Pot/Mag/Calc/Chlor/Acet 00409-5779-01 Electrolyte-Mb Solution/D5W 00990-7372-03 Electrolyte-R (Ph 7.4) 00990-7670-03 Electrolyte-M Solution/D5W 00990-7965-09 Electrolyte-R Solution 00990-7967-09 Electrolyte-R Solution/D5W 00990-7968-09

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Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

LACTATED RINGERS SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL Injection, Solution

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