Label: NOREPINEPHRINE BITARTRATE injection, solution

  • NDC Code(s): 0338-0108-20, 0338-0112-20
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 15, 2021

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use NOREPINEPHRINE BITARTRATE IN DEXTROSE injection safely and effectively. See full prescribing information for NOREPINEPHRINE BITARTRATE IN DEXTROSE injection.
    NOREPINEPHRINE BITARTRATE IN DEXTROSE injection, for intravenous use
    Initial U.S. Approval: 1950

    INDICATIONS AND USAGE

    Norepinephrine Bitartrate in Dextrose Injection is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states. (1)

    DOSAGE AND ADMINISTRATION

    No further dilution prior to infusion is required. (2.1)
    Initiate at 8 to 12 mcg/min, and adjust the rate to maintain blood pressure sufficient to maintain the circulation of vital organs. (2.2)
    The average maintenance dose ranges from 2 to 4 mcg/min. (2.2)

    DOSAGE FORMS AND STRENGTHS

    Injection: 250-mL single dose-containers with (3)

     
    4 mg equivalent of norepinephrine (16 mcg/mL) in 5% dextrose.
    8 mg equivalent of norepinephrine (32 mcg/mL) in 5% dextrose.

    CONTRAINDICATIONS

    None. (4)

    WARNINGS AND PRECAUTIONS

    Tissue Ischemia: Infuse Norepinephrine Bitartrate in Dextrose Injection into a large vein. To prevent sloughing and necrosis in areas in with extravasation, infiltrate the area with an adrenergic blocking agent in saline. (5.1)
    Hypotension After Abrupt Discontinuation: Gradually taper a norepinephrine infusion to prevent hypotension. (5.2)
    Cardiac Arrhythmias: Norepinephrine Bitartrate in Dextrose Injection may cause arrhythmias. Monitor cardiac function in patients with underlying heart disease. (5.3)

    ADVERSE REACTIONS

    Serious adverse reactions are described in greater detail in other sections [see Warnings and Precautions (5.1, 5.2, & 5.3)].
    Most common adverse reactions are hypertension, bradycardia, ischemic injury, anxiety, headache, respiratory difficulty, pulmonary edema, and extravasation necrosis at injection site. (6)

    To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    DRUG INTERACTIONS

    Monoamine oxidase inhibitors (MAOI) or tricyclic antidepressants of the triptyline or imipramine types may result in hypertension. (7.1, 7.2)
    Antidiabetics: Norepinephrine can decrease insulin sensitivity and raise blood glucose (7.3)
    Cyclopropane and halothane anesthetics increase cardiac autonomic irritability. (7.4)

    USE IN SPECIFIC POPULATIONS

    Elderly patients may be at greater risk of developing adverse reactions (8.5)

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 1/2021

  • Table of Contents
  • 1 INDICATIONS AND USAGE

    Norepinephrine Bitartrate in Dextrose Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.

  • 2 DOSAGE AND ADMINISTRATION

    2.1 Important Dosage and Administration Instructions

    Correct Hypovolemia

    Address hypovolemia before initiation of Norepinephrine Bitartrate in Dextrose Injection therapy. If the patient does not respond to therapy, suspect occult hypovolemia [see Warnings and Precautions (5.1)].

    Administration

    Norepinephrine Bitartrate in Dextrose Injection is a ready to administer product that requires no further dilution prior to infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate.

    Infuse Norepinephrine Bitartrate in Dextrose Injection into a large vein. Avoid infusions into the veins of the leg in the elderly or in patients with occlusive vascular disease of the legs [see Warnings and Precautions (5.1)]. Avoid using a catheter-tie-in technique.

    The choice of appropriate concentration of Norepinephrine Bitartrate in Dextrose Injection depends on clinical fluid volume requirements. Use higher concentration solutions in patients requiring fluid restriction.

    Discontinuation

    When discontinuing the infusion, reduce the flow rate gradually. Avoid abrupt withdrawal.

    2.2 Dosage

    After an initial dosage of 8 to 12 mcg per minute via intravenous infusion, assess patient response and adjust dosage to maintain desired hemodynamic effect. Monitor blood pressure every two minutes until the desired hemodynamic effect is achieved, and then monitor blood pressure every five minutes for the duration of the infusion.

    Typical maintenance intravenous dosage is 2 to 4 mcg per minute.

    2.3 Drug Incompatibilities

    Avoid contact with iron salts, alkalis, or oxidizing agents.

    Whole blood or plasma, if indicated to increase blood volume, should be administered separately.

  • 3 DOSAGE FORMS AND STRENGTHS

    Injection: Norepinephrine bitartrate in 5% dextrose is a colorless to slightly yellow solution for intravenous infusion, supplied in 250-mL single dose containers as:

    4 mg equivalent of norepinephrine (16 mcg/mL).
    8 mg equivalent of norepinephrine (32 mcg/mL).
  • 4 CONTRAINDICATIONS

    None.

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Tissue Ischemia

    Administration of Norepinephrine Bitartrate in Dextrose Injection to patients who are hypotensive from hypovolemia can result in severe peripheral and visceral vasoconstriction, decreased renal perfusion and reduced urine output, tissue hypoxia, lactic acidosis, and reduced systemic blood flow despite “normal” blood pressure. Address hypovolemia prior to initiating Norepinephrine Bitartrate in Dextrose Injection [see Dosage and Administration (2.1)]. Avoid Norepinephrine Bitartrate in Dextrose Injection in patients with mesenteric or peripheral vascular thrombosis, as this may increase ischemia and extend the area of infarction.

    Gangrene of the extremities has occurred in patients with occlusive or thrombotic vascular disease or who received prolonged or high dose infusions. Monitor for changes to the skin of the extremities in susceptible patients.

    Extravasation of Norepinephrine Bitartrate in Dextrose Injection may cause necrosis and sloughing of surrounding tissue. To reduce the risk of extravasation, infuse into a large vein, check the infusion site frequently for free flow, and monitor for signs of extravasation [see Dosage and Administration (2.1)].

    Emergency Treatment of Extravasation

    To prevent sloughing and necrosis in areas in which extravasation has occurred, infiltrate the ischemic area as soon as possible, using a syringe with a fine hypodermic needle with 5 to 10 mg of phentolamine mesylate in 10 to 15 mL of 0.9% Sodium Chloride Injection in adults.

    Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours.

    5.2 Hypotension after Abrupt Discontinuation

    Sudden cessation of the infusion rate may result in marked hypotension. When discontinuing the infusion, gradually reduce the Norepinephrine Bitartrate in Dextrose Injection infusion rate while expanding blood volume with intravenous fluids.

    5.3 Cardiac Arrhythmias

    Norepinephrine Bitartrate in Dextrose Injection elevates intracellular calcium concentrations and may cause arrhythmias, particularly in the setting of hypoxia or hypercarbia. Perform continuous cardiac monitoring of patients with arrhythmias.

  • 6 ADVERSE REACTIONS

    The following serious adverse reactions are described in greater detail in other sections:

    Tissue Ischemia [see Warnings and Precautions (5.1)]
    Hypotension [see Warnings and Precautions (5.2)]
    Cardiac Arrhythmias [see Warnings and Precautions (5.3)]

    The most common adverse reactions are hypertension and bradycardia.

    The following adverse reactions can occur:

    Nervous system disorders: Anxiety, headache

    Respiratory disorders: Respiratory difficulty, pulmonary edema

    General disorders and administration site conditions: Extravasation, injection site necrosis [see Warnings and Precautions (5.1)].

  • 7 DRUG INTERACTIONS

    7.1 MAO-Inhibiting Drugs

    Co-administration of Norepinephrine Bitartrate in Dextrose Injection with monoamine oxidase (MAO) inhibitors or other drugs with MAO-inhibiting properties (e.g., linezolid) can cause severe, prolonged hypertension.

    If administration of Norepinephrine Bitartrate in Dextrose Injection cannot be avoided in patients who recently have received any of these drugs and in whom, after discontinuation, MAO activity has not yet sufficiently recovered, monitor for hypertension.

    7.2 Tricyclic Antidepressants

    Co-administration of Norepinephrine Bitartrate in Dextrose Injection with tricyclic antidepressants (including amitriptyline, nortriptyline, protriptyline, clomipramine, desipramine, imipramine) can cause severe, prolonged hypertension. If administration of Norepinephrine Bitartrate in Dextrose Injection cannot be avoided in these patients, monitor for hypertension.

    7.3 Antidiabetics

    Norepinephrine Bitartrate in Dextrose Injection can decrease insulin sensitivity and raise blood glucose. Monitor glucose and consider dosage adjustment of antidiabetic drugs.

    7.4 Halogenated Anesthetics

    Concomitant use of Norepinephrine Bitartrate in Dextrose Injection with halogenated anesthetics (e.g., cyclopropane, desflurane, enflurane, isoflurane, and sevoflurane) may lead to ventricular tachycardia or ventricular fibrillation. Monitor cardiac rhythm in patients receiving concomitant halogenated anesthetics.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Risk Summary

    Limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated. (see Clinical Considerations). In animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. Clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see Data). Increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approximately 2 times the maximum recommended dose on a mg/m3 basis for four days during organogenesis (see Data).

    The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

    Clinical Considerations

    Disease-associated maternal and/or embryo/fetal risk

    Hypotension associated with septic shock, myocardial infarction, and stroke are medical emergencies in pregnancy which can be fatal if left untreated. Delaying treatment in pregnant women with hypotension associated with septic shock, myocardial infarction and stroke may increase the risk of maternal and fetal morbidity and mortality. Life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of norepinephrine on the fetus.

    Data

    Animal Data

    A study in pregnant sheep receiving high doses of intravenous norepinephrine (40 mcg/min, at approximately 10 times the average maintenance dose of 2-4 mcg/min in human, on a mg/kg basis) exhibited a significant decrease in maternal placental blood flow. Decreases in fetal oxygenation, urine and lung liquid flow were also observed.

    Norepinephrine administration to pregnant rats on Gestation Day 16 or 17 resulted in cataract production in rat fetuses.

    In hamsters, an increased number of resorptions (29.1% in study group vs. 3.4% in control group), fetal microscopic liver abnormalities and delayed skeletal ossification were observed at approximately 2 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day from Gestation Day 7-10).

    8.2 Lactation

    Risk Summary

    There are no data on the presence of norepinephrine in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. Clinically relevant exposure to the infant is not expected based on the short half-life and poor oral bioavailability of norepinephrine.

    8.4 Pediatric Use

    Safety and effectiveness in pediatric patients have not been established.

    8.5 Geriatric Use

    Clinical studies of norepinephrine 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.

    Avoid administration of Norepinephrine Bitartrate in Dextrose Injection into the veins in the leg in elderly patients [see Warnings and Precautions (5.1)].

  • 10 OVERDOSAGE

    Overdosage with Norepinephrine Bitartrate in Dextrose Injection may result in headache, severe hypertension, reflex bradycardia, marked increase in peripheral resistance, and decreased cardiac output.

    In case of overdosage, discontinue Norepinephrine Bitartrate in Dextrose Injection until the condition of the patient stabilizes.

  • 11 DESCRIPTION

    Norepinephrine Bitartrate in Dextrose Injection contains norepinephrine, a sympathomimetic amine. Norepinephrine is sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine which differs from epinephrine by the absence of a methyl group on the nitrogen atom.

    Chemically, norepinephrine bitartrate monohydrate is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate and has the following structural formula:

    Structural Formula

    Norepinephrine is sparingly soluble in water, very slightly soluble in alcohol and ether, and readily soluble in acids.

    Norepinephrine Bitartrate in Dextrose Injection is supplied as a sterile aqueous solution administered by intravenous infusion. Each mL contains the equivalent of 16 or 32 micrograms of norepinephrine base supplied as 31.90 and 63.80 micrograms per mL of norepinephrine bitartrate monohydrate. It contains dextrose monohydrate (50 mg/mL) and may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. It has a pH of 3.5 – 3.9. The air in the containers has been displaced by nitrogen gas.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Norepinephrine is a peripheral vasoconstrictor (alpha-adrenergic action) and an inotropic stimulator of the heart and dilator of coronary arteries (beta-adrenergic action).

    12.2 Pharmacodynamics

    The primary pharmacodynamic effects of norepinephrine are cardiac stimulation and vasoconstriction. Cardiac output is generally unaffected, although it can be decreased, and total peripheral resistance is also elevated. The elevation in resistance and pressure result in reflex vagal activity, which slows the heart rate and increases stroke volume. The elevation in vascular tone or resistance reduces blood flow to the major abdominal organs as well as to skeletal muscle. Coronary blood flow is substantially increased secondary to the indirect effects of alpha stimulation. After intravenous administration, a pressor response occurs rapidly and reaches steady state within 5 minutes. The pharmacologic actions of norepinephrine are terminated primarily by uptake and metabolism in sympathetic nerve endings. The pressor action stops within 1-2 minutes after the infusion is discontinued.

    12.3 Pharmacokinetics

    Absorption

    Following initiation of intravenous infusion, the steady state plasma concentration is achieved in 5 min.

    Distribution

    Plasma protein binding of norepinephrine is approximately 25%. It is mainly bound to plasma albumin and to a smaller extent to prealbumin and alpha 1-acid glycoprotein. The volume of distribution is 8.8 L. Norepinephrine localizes mainly in sympathetic nervous tissue. It crosses the placenta but not the blood-brain barrier.

    Elimination

    The mean half-life of norepinephrine is approximately 2.4 min. The average metabolic clearance is 3.1 L/min.

    Metabolism

    Norepinephrine is metabolized in the liver and other tissues by a combination of reactions involving the enzymes catechol-O-methyltransferase (COMT) and monoamine oxidase (MAO). The major metabolites are normetanephrine and 3-methoxy-4-hydroxy mandelic acid (vanillylmandelic acid, VMA), both of which are inactive. Other inactive metabolites include 3-methoxy-4-hydroxyphenylglycol, 3,4-dihydroxymandelic acid, and 3,4-dihydroxyphenylglycol.

    Excretion

    Norepinephrine metabolites are excreted in urine primarily as the sulfate conjugates and, to a lesser extent, as the glucuronide conjugates. Only small quantities of norepinephrine are excreted unchanged.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    Carcinogenesis, mutagenesis, and fertility studies have not been performed.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Norepinephrine Bitartrate in Dextrose Injection intravenous infusion is available in single-dose, ready-to-use containers in an amber/foil overwrap. Each 250 mL of Norepinephrine Bitartrate in Dextrose Injection , 4 mg/250 mL and 8 mg/250 mL contains the equivalent of 4 mg and 8 mg of norepinephrine, respectively (provided as norepinephrine bitartrate monohydrate). Norepinephrine Bitartrate in Dextrose Injection is available in the following:

    Product Description

    NDC Number

    Twenty (20) 4 mg/250 mL containers

    NDC 0338-0112-20

    Twenty (20) 8 mg/250 mL containers

    NDC 0338-0108-20

    Store between 2°C to 8°C (36°F to 46°F) in overwrap to protect from light.

    Norepinephrine Bitartrate in Dextrose Injection may be stored at room temperature up to 25°C (77°F) for up to 90 days upon removal from refrigeration. Once removed from refrigeration, the overwrap should be marked to indicate the revised 90 day expiration date and the product should not be returned to the refrigerator after it has been stored at room temperature. Once the overwrap is removed, the bag can be stored at room temperature for up to 30 days. Discard Norepinephrine Bitartrate in Dextrose Injection after 90 days if stored at room temperature or 30 days from overwrap removal.

    The storage conditions and expiration periods are summarized in the following table.

    *
    Following removal from refrigeration

    In Overwrap

    Refrigerated

    2°C to 8°C (36°F to 46°F)

    In Overwrap

    Room Temperature*

    20°C to 25°C (68°F to 77°F)

    Out of Overwrap

    Room Temperature*

    20°C to 25°C (68°F to 77°F)

    Until manufacturer expiration date

    90 days or until manufacturer expiration date, whichever is earlier

    30 days or until manufacturer expiration date, whichever is earlier

  • 17 PATIENT COUNSELING INFORMATION

    Risk of Tissue Damage

    Advise the patient, family, or caregiver to report signs of extravasation urgently [see Warnings and Precautions (5.1)].

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Baxter Healthcare Corporation
    Deerfield, IL 60015 USA

    Made in Ireland

    Baxter and Viaflo are trademarks of Baxter International, Inc.

    CB-30-02-675

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Representative Norepinephrene Container Label  0338-0112-20 DRAFT

    Container Label

    EZPE7748
    NDC 0338-0112-20
    Baxter Logo
    250 mL

    NORepinephrine Bitartrate
    in 5% Dextrose Injection

    4 mg / 250 mL (16 mg / mL)
    For Intravenous Infusion Only

    Each 100mL of sterile, nonpyrogenic solution contains: Norepinephrine
    Bitartrate Monohydrate USP equivalent to
    1.6 mg norepinephrine and 5 g Dextrose Monohydrate in Water for
    Injection, USP. May contain hydrochloric acid and/or sodium hydroxide
    for pH adjustment.

    Single Dose Only – Discard unused portion. For Intravenous Use.
    Recommended dosage: See prescribing information.
    Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15° C to
    30°C (59°F to 86° F) [see USP Controlled Room Temperature.] Protect
    from light. Keep in overwrap until ready to use. The bag should be used
    within 30 days of removal from overwrap.
    VIAFLO container is not made with natural rubber latex, DEHP, or PVC.
    Rx Only

    Baxter Healthcare Corporation
    Deerfield, IL 60015 USA
    Made in Ireland

    1
    CB-35-04-787

    VIAFLO container

    Symbol
    07
    0

    Do not use
    this port

    Symbol

    Barcode
    (01)00303380112203

    LOT

    EXP

    Representative Norepinephrene Container Label  0338-0108-20 DRAFT

    Container Label

    EZPE7788
    Baxter Logo

    NDC 0338-0108-20
    250 mL

    NORepinephrine Bitartrate
    in 5% Dextrose Injection

    8 mg / 250 mL
    (32 mcg / mL)
    For Intravenous Infusion Only

    Each 100mL of sterile, nonpyrogenic solution contains: Norepinephrine
    Bitartrate Monohydrate USP equivalent to
    3.2 mg norepinephrine and 5 g Dextrose Monohydrate in Water for
    Injection, USP. May contain hydrochloric acid and/or sodium hydroxide
    for pH adjustment.

    Single Dose Only – Discard unused portion. For Intravenous Use.
    Recommended dosage: See prescribing information.
    Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to
    30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Protect
    from light. Keep in overwrap until ready to use. The bag should be used
    within 30 days of removal from overwrap.
    VIAFLO container is not made with natural rubber latex, DEHP, or
    PVC.
    Rx Only

    Baxter Healthcare Corporation
    Deerfield, IL 60015 USA
    Made in Ireland

    1
    CB-35-04-788

    VIAFLO container

    Do not use
    this port

    Symbol

    Symbol
    07
    0

    Barcode
    (01)00303380108206

    LOT

    EXP

  • INGREDIENTS AND APPEARANCE
    NOREPINEPHRINE BITARTRATE 
    norepinephrine bitartrate injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-0112
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NOREPINEPHRINE BITARTRATE (UNII: IFY5PE3ZRW) (NOREPINEPHRINE - UNII:X4W3ENH1CV) NOREPINEPHRINE4 mg  in 250 mL
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) 12.5 g  in 250 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-0112-2020 in 1 CARTON01/15/2021
    1250 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21431301/15/2021
    NOREPINEPHRINE BITARTRATE 
    norepinephrine bitartrate injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-0108
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NOREPINEPHRINE BITARTRATE (UNII: IFY5PE3ZRW) (NOREPINEPHRINE - UNII:X4W3ENH1CV) NOREPINEPHRINE8 mg  in 250 mL
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) 12.5 g  in 250 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-0108-2020 in 1 CARTON01/15/2021
    1250 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21431301/15/2021
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare S.A.988899845ANALYSIS(0338-0108, 0338-0112) , MANUFACTURE(0338-0108, 0338-0112) , LABEL(0338-0108, 0338-0112) , PACK(0338-0108, 0338-0112) , STERILIZE(0338-0108, 0338-0112)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bieffe Medital S.p.A.437668413ANALYSIS(0338-0108, 0338-0112)