Label: DEXTROSE IN LACTATED RINGERS- dextrose, sodium chloride, sodium lactate, potassium chloride, and calcium chloride injection, solution

  • NDC Code(s): 0264-7751-00, 0264-7751-10
  • Packager: B. Braun Medical Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 1, 2021

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    Each 100 mL of 5% Dextrose in Lactated Ringer's Injection contains:
    Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.6 g
    Sodium Lactate 0.31 g; Potassium Chloride USP 0.03 g
    Calcium Chloride Dihydrate USP 0.02 g
    Water for Injection USP qs

    pH adjusted with Hydrochloric Acid NF
    pH: 4.6 (4.0–6.0)
    Calories per liter: 170
    Calculated Osmolarity: 530 mOsmol/liter, hypertonic

    Concentration of Electrolytes (mEq/liter): Sodium 130;     Potassium 4;
    Calcium 3;      Chloride 112;     Lactate (CH3CH(OH)COO) 28

    5% Dextrose in Lactated Ringer's Injection is sterile, nonpyrogenic and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration.

    The formulas of the active ingredients are:

    IngredientsMolecular FormulaMolecular Weight
     Sodium Chloride USP NaCl   58.44
     Sodium Lactate CH3CH(OH)COONa 112.06
     Potassium Chloride USP KCl   74.55
     Calcium Chloride Dihydrate USP CaCl2•2H2O 147.02
     Hydrous Dextrose USP Chemical Structure 198.17

    Not made with natural rubber latex, PVC or DEHP.

    The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

    Addition of medication should be accomplished using complete aseptic technique.

    The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.

  • CLINICAL PHARMACOLOGY

    5% Dextrose in Lactated Ringer's Injection provides electrolytes and calories, and is a source of water for hydration. It is capable of inducing diuresis depending on the clinical condition of the patient. This solution also contains lactate which produces a metabolic alkalinizing effect.

    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. Potassium, the principal cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart.

    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. Calcium, an important cation, provides the framework of bones and teeth in the form of calcium phosphate and calcium carbonate. In the ionized form, calcium is essential for the functional mechanism of the clotting of blood, normal cardiac function, and regulation of neuromuscular irritability.

    Sodium lactate is a racemic salt containing both the levo form, which is oxidized by the liver to bicarbonate, and the dextro form, which is converted to glycogen. Lactate is slowly metabolized to carbon dioxide and water, accepting one hydrogen ion and resulting in the formation of bicarbonate for the lactate consumed. These reactions depend on oxidative cellular activity.

    Dextrose provides a source of calories. Dextrose is readily metabolized, may decrease losses of body protein and nitrogen, promotes glycogen deposition and decreases or prevents ketosis if sufficient doses are provided.

  • INDICATIONS AND USAGE

    This solution is indicated for use in adults and pediatric patients as a source of electrolytes, calories and water for hydration.

  • CONTRAINDICATIONS

    The use of 5% Dextrose in Lactated Ringer’s Injection is contraindicated in neonates (28 days of age or younger) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone-calcium salt precipitation in the neonate’s bloodstream [see Warnings, Drug Interactions, Pediatric Use].

    This solution is contraindicated where the administration of sodium, potassium, calcium, chloride or lactate could be clinically detrimental.

    Lactate administration is contraindicated in severe metabolic acidosis or alkalosis, and in severe liver disease or anoxic states which affect lactate metabolism.

    Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

  • WARNINGS

    Precipitation with Ceftriaxone

    Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with calcium-containing solutions, such as 5% Dextrose in Lactated Ringer’s Injection, in the same intravenous administration line. Do not administer ceftriaxone simultaneously with 5% Dextrose in Lactated Ringer’s Injection via a Y-site.

    Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone resulting from calcium-ceftriaxone precipitates in the lungs and kidneys, even when separate infusion lines were used. 5% Dextrose in Lactated Ringer’s Injection is contraindicated in neonates receiving ceftriaxone.

    However, in patients other than neonates, ceftriaxone and 5% Dextrose in Lactated Ringer’s Injection may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid. [see Contraindications, Warnings, Drug Interactions, Pediatric Use].

    Solutions containing lactate are not for use in the treatment of lactic acidosis.

    Solutions containing lactate should be used with great care in patients with metabolic or respiratory alkalosis, and in those conditions in which there is an increased level or an impaired utilization of lactate, such as severe hepatic insufficiency.

    The administration of intravenous solutions 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 concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

    Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema.

    Solutions containing potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium ions retention is present.

    In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.

    Solutions containing calcium ions should not be administered through the same administration set as blood because of the likelihood of coagulation.

  • PRECAUTIONS

    General

    This solution should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation.

    Extraordinary electrolytes losses such as may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation.

    Additional essential electrolytes, minerals and vitamins should be supplied as needed.

    Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients.

    Care should be exercised in administering solutions containing sodium or potassium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly.

    The osmolarity of 5% Dextrose in Lactated Ringer’s Injection is 530 mOsmol/liter (calc). Administration of substantially hypertonic solutions may cause venous irritation, including phlebitis.

    Solutions containing calcium should be used with caution in the presence of cardiac disease, particularly when accompanied by renal disease. Parenteral calcium should be administered with extreme caution to patients receiving digitalis preparations.

    Solutions containing lactate should be used with caution. Excess administration may result in metabolic alkalosis.

    The conversion of lactate to bicarbonate is markedly delayed in the presence of tissue anoxia and reduced capacity of the liver to metabolize lactate. This may occur under conditions such as metabolic acidosis associated with circulatory insufficiency, extracorporeal circulation, hypothermia, glycogen storage disease, liver dysfunction, respiratory alkalosis, shock or cardiac decompensation.

    Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason.

    To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.

    Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container.

    If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (greater than 300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container.

    This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

    Use only if solution is clear and container and seals are intact.

    Laboratory Tests

    Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in this or an alternative solution.

    Drug Interactions

    Ceftriaxone

    Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with calcium-containing solutions, such as 5% Dextrose in Lactated Ringer’s Injection, in the same intravenous administration line. Do not administer ceftriaxone simultaneously with 5% Dextrose in Lactated Ringer’s Injection via a Y-site. However, in patients other than neonates, ceftriaxone and 5% Dextrose in Lactated Ringer’s Injection may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid [see Warnings, Dosage and Administration].

    Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone resulting from calcium-ceftriaxone precipitates in the lungs and kidneys, even when separate infusion lines were used [see Contraindications, Warnings, Pediatric Use, Dosage and Administration].

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

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Studies with 5% Dextrose in Lactated Ringer's Injection have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

    Pregnancy: Teratogenic Effects

    Animal reproduction studies have not been conducted with 5% Dextrose in Lactated Ringer's Injection. It is also not known whether 5% Dextrose in Lactated Ringer's Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 5% Dextrose in Lactated Ringer's Injection should be given to a pregnant woman only if clearly needed.

    Labor and Delivery

    The effects of 5% Dextrose in Lactated Ringer's Injection on the duration of labor or delivery, on the possibility that forceps delivery or other intervention or resuscitation of the newborn will be necessary, and on the later growth, development, and functional maturation of the child are unknown.

    As reported in the literature, 5% Dextrose in Lactated Ringer's Injection has been administered during labor and delivery. Caution should be exercised, and the fluid balance, glucose and electrolyte concentrations, and acid-base balance, of both mother and fetus should be evaluated periodically or whenever warranted by the condition of the patient or fetus.

    Nursing Mothers

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 5% Dextrose in Lactated Ringer's Injection is administered to a nursing woman.

    Pediatric Use

    Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone resulting from calcium-ceftriaxone precipitates in the lungs and kidneys, even when separate infusion lines were used. 5% Dextrose in Lactated Ringer’s Injection is contraindicated in neonates receiving ceftriaxone [see Contraindications, Warnings, Drug Interactions].

    Safety and effectiveness of 5% Dextrose in Lactated Ringer's Injection in pediatric patients has not been established by adequate and well-controlled studies. However, as referenced in the medical literature, potassium chloride injection has been used to treat pediatric patients with potassium deficiency when oral replacement therapy is not feasible.

    For patients receiving potassium supplement at greater than maintenance rates, frequent monitoring of serum potassium levels and serial EKGs are recommended.

    Dextrose is safe and effective for the stated indications in pediatric patients (see INDICATIONS AND USAGE). As reported in the literature, the dosage selection and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.

    In neonates or in very small infants even small volumes of fluid may affect fluid and electrolyte balance. Care must be exercised in treatment of neonates, especially pre-term neonates, whose renal function may be immature and whose ability to excrete fluid and solute loads may be limited. Fluid intake, urine output, and serum glucose and electrolytes should be monitored closely.

    See WARNINGS and DOSAGE AND ADMINISTRATION.

    Geriatric Use

    Clinical studies of 5% Dextrose in 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 elderly and younger patients.

    In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

    This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions 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.

    See WARNINGS.

  • 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.

    Too rapid infusion of hypertonic solutions may cause local pain and venous irritation. Rate of administration should be adjusted according to tolerance. Use of the largest peripheral vein and a small bore needle is recommended. (See DOSAGE AND ADMINISTRATION.)

    Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential.

    Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume.

    Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain and diarrhea. The signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities and cardiac arrest. Potassium deficits result in disruption of neuromuscular function, and intestinal ileus and dilatation.

    If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect.

    Abnormally high plasma levels of calcium can result in depression, amnesia, headaches, drowsiness, disorientation, syncope, hallucinations, hypotonia of both skeletal and smooth muscles, dysphagia, arrhythmias and coma. Calcium deficits can result in neuromuscular hyperexcitability, including cramps and convulsions.

    Although the metabolism of lactate to bicarbonate is a relatively slow process, aggressive administration of sodium lactate may result in metabolic alkalosis. Careful monitoring of blood acid-base balance is essential during the administration of sodium lactate.

    The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing information for drug additives to be administered in this manner should be consulted.

    If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

    Other manifestations of hypersensitivity/infusion reactions: decreased heart rate, tachycardia, blood pressure decreased, respiratory distress, laryngeal edema, flushing, throat irritation, paresthesias, hypoesthesia oral, dysgeusia, anxiety, headache, and sneezing.

    Hyperkalemia

    Hypervolemia

    Other infusion site reactions: infection at the site of injection, phlebitis, extravasation, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pain, infusion site burning.

  • OVERDOSAGE

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

  • DOSAGE AND ADMINISTRATION

    This solution is for intravenous use only.

    Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

    When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.

    Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

    The presence of calcium ions in this solution should be considered when phosphate is present in additive solutions, in order to avoid precipitation.

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

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

    Ceftriaxone must not be administered simultaneously with calcium-containing intravenous solutions such as 5% Dextrose in Lactated Ringer’s Injection via a Y-site. However, in patients other than neonates, ceftriaxone and 5% Dextrose in Lactated Ringer’s Injection may be administered sequentially if the infusion
    lines are thoroughly are thoroughly flushed between infusions with a compatible fluid [see Contraindications, Warnings, Drug Interactions, Pediatric Use].

    Pediatric Use

    There is no specific pediatric dose. The dose is dependent on weight, clinical condition and laboratory results. See WARNINGS and PRECAUTIONS.

  • HOW SUPPLIED

    5% Dextrose in Lactated Ringer's Injection is supplied sterile and nonpyrogenic in EXCEL® Containers. The 1000 mL containers are packaged 12 per case and the 500 mL containers are packaged 24 per case.

    NDCREFSize
     5% Dextrose in Lactated Ringer's Injection
     0264-7751-00 L7510 1000 mL
     0264-7751-10 L7511   500 mL

    Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

  • SPL UNCLASSIFIED SECTION

    Rx only

    Revised: November 2021

    EXCEL is a registered trademark of B. Braun Medical Inc.

  • Directions for Use of EXCEL Container

    Caution: Do not use plastic containers in series connection.

    To Open

    Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration.

    NOTE: Before use, perform the following checks:

    Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.

    Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used.

    Use only if solution is clear and container and seals are intact.

    Preparation for Administration

    1. Remove plastic protector from sterile set port at bottom of container.
    2. Attach administration set. Refer to complete directions accompanying set.

    To Add Medication

    Warning: Some additives may be incompatible.

    To Add Medication Before Solution Administration

    1. Prepare medication site.
    2. Using syringe with 18–22 gauge needle, puncture medication port and inner diaphragm and inject.
    3. Squeeze and tap ports while ports are upright and mix solution and medication thoroughly.

    To Add Medication During Solution Administration

    1. Close clamp on the set.
    2. Prepare medication site.
    3. Using syringe with 18–22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject.
    4. Remove container from IV pole and/or turn to an upright position.
    5. Evacuate both ports by tapping and squeezing them while container is in the upright position.
    6. Mix solution and medication thoroughly.
    7. Return container to in use position and continue administration.
  • SPL UNCLASSIFIED SECTION

    B. Braun Medical Inc.
    Bethlehem, PA 18018-3524 USA
    1-800-227-2862

    Y36-003-026   LD-380-5

  • PRINCIPAL DISPLAY PANEL - 1000 mL Container Label

    5% Dextrose in
    Lactated Ringer's
    Injection

    REF L7510
    NDC 0264-7751-00

    1000 mL
    EXCEL® CONTAINER

    Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium
    Chloride USP 0.6 g; Sodium Lactate 0.31 g; Potassium Chloride
    USP 0.03 g; Calcium Chloride•2H2O USP 0.02 g; Water for
    Injection USP qs

    pH adjusted with HCl NF
    pH: 4.6 (4.0-6.0); Calc. Osmolarity: 530 mOsmol/liter,
    hypertonic

    Electrolytes (mEq/liter):   Na+ 130;    K+ 4;     Ca++ 3;
                                            CI 112;     Lactate 28

    Sterile, nonpyrogenic. Single dose container. Do not use in series
    connection. For intravenous use only. Use only if solution is clear
    and container and seals are intact.

    WARNINGS: NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS.
    Do Not Administer Simultaneously With Blood. Some additives may
    be incompatible. Consult with pharmacist. When introducing
    additives, use aseptic techniques. Mix thoroughly. Do not store.

    Recommended Storage: Room temperature (25°C). Avoid excessive
    heat. Protect from freezing. See Package Insert.

    Do not remove overwrap until ready for use. After removing the
    overwrap, check for minute leaks by squeezing container firmly. If
    leaks are found, discard solution as sterility may be impaired.

    Not made with natural rubber latex, PVC or DEHP.

    Rx only

    recycle symbol

    EXCEL is a registered trademark of B. Braun Medical Inc.

    B. Braun Medical Inc.
    Bethlehem, PA 18018-3524 USA
    1-800-227-2862

    Y94-003-220   LD-141-4

    EXP
    LOT

    1000 mL Container Label L7510
  • PRINCIPAL DISPLAY PANEL - 500 mL Container Label

    5% Dextrose in
    Lactated Ringer's Injection

    REF L7511
    NDC 0264-7751-10

    500 mL
    EXCEL® CONTAINER

    Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium Chloride
    USP 0.6 g; Sodium Lactate 0.31 g; Potassium Chloride USP 0.03 g;
    Calcium Chloride•2H2O USP 0.02 g; Water for Injection USP qs

    pH adjusted with HCl NF
    pH: 4.6 (4.0-6.0); Calc. Osmolarity: 530 mOsmol/liter, hypertonic
    Electrolytes (mEq/liter):   Na+ 130;     K+ 4;     Ca++ 3;     Cl 112;     Lactate 28

    Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For
    intravenous use only. Use only if solution is clear and container and seals are intact.

    WARNINGS: NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS.
    Do Not Administer Simultaneously With Blood. Some additives may be
    incompatible. Consult with pharmacist. When introducing additives, use aseptic
    techniques. Mix thoroughly. Do not store.

    Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect
    from freezing. See Package Insert.

    Do not remove overwrap until ready for use. After removing the overwrap, check for
    minute leaks by squeezing container firmly. If leaks are found, discard solution
    as sterility may be impaired.

    Not made with natural rubber latex, PVC or DEHP.

    Rx only

    recycle symbol

    EXCEL is a registered trademark of B. Braun Medical Inc.

    B. Braun Medical Inc.
    Bethlehem, PA 18018-3524 USA
    1-800-227-2862

    Y94-003-222
    LD-140-4

    EXP
    LOT

    500 mL Container Label L7511
  • INGREDIENTS AND APPEARANCE
    DEXTROSE IN LACTATED RINGERS 
    dextrose, sodium chloride, sodium lactate, potassium chloride, and calcium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0264-7751
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE5 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.6 g  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (LACTIC ACID - UNII:33X04XA5AT) SODIUM LACTATE0.31 g  in 100 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE0.03 g  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE0.02 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0264-7751-0012 in 1 CASE02/24/1988
    11000 mL in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:0264-7751-1024 in 1 CASE02/24/1988
    2500 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01963402/24/1988
    Labeler - B. Braun Medical Inc. (002397347)