Naropin

1 Indications and Usage NAROPIN is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia : epidural block for surgery including cesarean section; major nerve block; local infiltration Acute Pain Management : epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration NAROPIN is an amide local anesthetic indicated in adults for the production of local or regional anesthesia for surgery and for acute pain management. (1) Surgical Anesthesia : epidural block for surgery including cesarean section; major nerve block; local infiltration Acute Pain Management : epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration

2 DOSAGE AND ADMINISTRATION See Table 1 for Dosage Recommendations ( 2.2 ) 2.1 Important Administration Instructions There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. NAROPIN is not approved for this use [see Warnings and Precautions ( 5.3 )] . The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should always be used. The smallest dose and concentration required to produce the desired result should be administered. The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. Patients in poor general condition due to aging or other compromising factors such as partial or complete heart conduction block, advanced liver disease or severe renal dysfunction require special attention although regional anesthesia is frequently indicated in these patients. To reduce the risk of potentially serious adverse reactions, attempts should be made to optimize the patient's condition before major blocks are performed, and the dosage should be adjusted accordingly. Use an adequate test dose (3 to 5 mL of a short acting local anesthetic solution containing epinephrine) prior to induction of complete block. This test dose should be repeated if the patient is moved in such a fashion as to have displaced the epidural catheter. Allow adequate time for onset of anesthesia following administration of each test dose. These products are intended for single dose and are free from preservatives. Any solution remaining from an opened container should be discarded promptly. In addition, continuous infusion bottles should not be left in place for more than 24 hours. 2.2 Dosage Recommendations Table 1 Dosage Recommendations * = Not Applicable † = The dose for a major nerve block must be adjusted according to site of administration and patient status. Supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anesthetic used [see Warnings and Precautions ( 5.7 )]. ‡ = Median dose of 21 mg per hour was administered by continuous infusion or by incremental injections (top-ups) over a median delivery time of 5.5 hours. § = Cumulative doses up to 770 mg of NAROPIN over 24 hours (intraoperative block plus postoperative infusion); Continuous epidural infusion at rates up to 28 mg per hour for 72 hours have been well tolerated in adults, i.e., 2016 mg plus surgical dose of approximately 100 to 150 mg as top-up. Conc. Volume Dose Onset min Duration hours mg/mL (%) mL mg SURGICAL ANESTHESIA Lumbar Epidural 5 (0.5%) 15 to 30 75 to 150 15 to 30 2 to 4 Administration 7.5 (0.75%) 15 to 25 113 to 188 10 to 20 3 to 5 Surgery 10 (1%) 15 to 20 150 to 200 10 to 20 4 to 6 Lumbar Epidural 5 (0.5%) 20 to 30 100 to 150 15 to 25 2 to 4 Administration 7.5 (0.75%) 15 to 20 113 to 150 10 to 20 3 to 5 Cesarean Section Thoracic Epidural 5 (0.5%) 5 to 15 25 to 75 10 to 20 n/a* Administration 7.5 (0.75%) 5 to 15 38 to 113 10 to 20 n/a* Surgery Major Nerve Block † 5 (0.5%) 35 to 50 175 to 250 15 to 30 5 to 8 (e.g., brachial plexus block) 7.5 (0.75%) 10 to 40 75 to 300 10 to 25 6 to 10 Field Block 5 (0.5%) 1 to 40 5 to 200 1 to 15 2 to 6 (e.g., minor nerve blocks and infiltration) LABOR PAIN MANAGEMENT Lumbar Epidural Administration Initial Dose 2 (0.2%) 10 to 20 20 to 40 10 to15 0.5 to 1.5 Continuous infusion ‡ 2 (0.2%) 6 to 14 mL/h 12 to 28 mg/h n/a* n/a* Incremental injections (top-up) ‡ 2 (0.2%) 10 to 15 mL/h 20 to 30 mg/h n/a* n/a* POSTOPERATIVE PAIN MANAGEMENT Lumbar Epidural Administration Continuous infusion § 2 (0.2%) 6 to 1 …

3 DOSAGE FORMS AND STRENGTHS NAROPIN ® (ropivacaine hydrochloride) injection is a clear, colorless, preservative-free solution available as: NAROPIN ® Single Dose Vials 0.2%, 20 mg per 10 mL (2 mg/mL), in 10 mL single-dose vial 0.2%, 40 mg per 20 mL (2 mg/mL), in 20 mL single-dose vial 0.5%, 100 mg per 20 mL (5 mg/mL), 20 mL single-dose vial 0.5%, 150 mg per 30 mL (5 mg/mL), 30 mL single-dose vial 0.75%, 150 mg per 20 mL (7.5 mg/mL), 20 mL single-dose vial 1%, 100 mg per 10 mL (10 mg/mL), 10 mL single-dose vial 1%, 200 mg per 20 mL (10 mg/mL), 20 mL single-dose vial NAROPIN ® Single Dose Infusion Bottles 0.2%, 200 mg per 100 mL (2 mg/mL), 100 mL single-dose infusion bottle 0.2%, 400 mg per 200 mL (2 mg/mL ), 200 mL single-dose infusion bottle 0.5%, 500 mg per 100 mL (5 mg/mL), 100 mL single-dose infusion bottle 0.5%, 1,000 mg per 200 mL (5 mg/mL ), 200 mL single-dose infusion bottle NAROPIN ® Plastic Polypropylene Ampule 0.2%, 20 mg per 10 mL (2 mg/mL), 10 mL single-dose polypropylene ampule 0.2%, 40 mg per 20 mL (2 mg/mL), 20 mL single-dose polypropylene ampule 0.5%, 100 mg per 20 mL (5 mg/mL), 20 mL single-dose polypropylene ampule 0.75%, 150 mg per 20 mL (7.5 mg/mL), 20 mL single-dose polypropylene ampule 1%, 100 mg per 10 mL (10 mg/mL), 10 mL single-dose polypropylene ampule 1%, 200 mg per 20 mL (10 mg/mL), 20 mL single-dose polypropylene ampule NAROPIN ® Single-Dose, Ready-to-Use, Polypropylene Flexible Bags 0.2%, 200 mg per 100 mL (2 mg/mL), 100 mL single-dose, ready-to-use, polypropylene flexible bag 0.2%, 400 mg per 200 mL (2 mg/mL), 200 mL fill in 250 mL single-dose, ready-to-use, polypropylene flexible bag. Injection: 2 mg/mL (0.2%), 5 mg/mL (0.5%), 7.5 mg/mL (0.75%) or 10 mg/mL (1%) in single-dose vials ( 3 ) Injection: 2 mg/mL (0.2%) or 5 mg/mL (0.5%) in single-dose infusion bottles ( 3 ) Injection: 2 mg/mL (0.2%), 5 mg/mL (0.5%), 7.5 mg/mL (0.75%) or 10 mg/mL (1%) in single-dose polypropylene ampules ( 3 ) Injection: 2 mg/mL (0.2%) in single-dose, ready-to-use, polypropylene flexible bag ( 3 )

4 CONTRAINDICATIONS NAROPIN is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type. History of hypersensitivity to local anesthetics of the amide type. ( 4 )

ADVERSE REACTIONS: To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Reactions to ropivacaine are characteristic of those associated with other amide-type local anesthetics. A major cause of adverse reactions to this group of drugs may be associated with excessive plasma levels, which may be due to overdosage, unintentional intravascular injection or slow metabolic degradation. The reported adverse events are derived from clinical studies conducted in the U.S. and other countries. The reference drug was usually bupivacaine. The studies used a variety of premedications, sedatives, and surgical procedures of varying length. A total of 3,988 patients have been exposed to Naropin at concentrations up to 1% in clinical trials. Each patient was counted once for each type of adverse event. Incidence ≥5% For the indications of epidural administration in surgery, cesarean section, postoperative pain management, peripheral nerve block, and local infiltration, the following treatment-emergent adverse events were reported with an incidence of ≥ 5% in all clinical studies (N=3988): hypotension (37%), nausea (24.8%), vomiting (11.6%), bradycardia (9.3%), fever (9.2%), pain (8%), postoperative complications (7.1%), anemia (6.1%), paresthesia (5.6%), headache (5.1%), pruritus (5.1%), and back pain (5%). Incidence 1 to 5% Urinary retention, dizziness, rigors, hypertension, tachycardia, anxiety, oliguria, hypoesthesia, chest pain, hypokalemia, dyspnea, cramps, and urinary tract infection. Incidence in Controlled Clinical Trials The reported adverse events are derived from controlled clinical studies with Naropin (concentrations ranged from 0.125% to 1% for Naropin and 0.25% to 0.75% for bupivacaine) in the U.S. and other countries involving 3,094 patients. Table 3A and 3B list adverse events (number and percentage) that occurred in at least 1% of Naropin-treated patients in these studies. The majority of patients receiving concentrations higher than 5 mg/mL (0.5%) were treated with Naropin. Table 3A Adverse Events Reported in ≥1% of Adult Patients Receiving Regional or Local Anesthesia (Surgery, Labor, Cesarean Section, Postoperative Pain Management, Peripheral Nerve Block and Local Infiltration) Adverse Reaction Naropin total N=1661 Bupivacaine total N=1433 N (%) N (%) Hypotension 536 (32.3) 408 (28.5) Nausea 283 (17) 207 (14.4) Vomiting 117 (7) 88 (6.1) Bradycardia 96 (5.8) 73 (5.1) Headache 84 (5.1) 68 (4.7) Paresthesia 82 (4.9) 57 (4) Back pain 73 (4.4) 75 (5.2) Pain 71 (4.3) 71 (5) Pruritus 63 (3.8) 40 (2.8) Fever 61 (3.7) 37 (2.6) Dizziness 42 (2.5) 23 (1.6) Rigors (Chills) 42 (2.5) 24 (1.7) Postoperative complications 41 (2.5) 44 (3.1) Hypoesthesia 27 (1.6) 24 (1.7) Urinary retention 23 (1.4) 20 (1.4) Progression of labor poor/failed 23 (1.4) 22 (1.5) Anxiety 21 (1.3) 11 (0.8) Breast disorder, breast-feeding 21 (1.3) 12 (0.8) Rhinitis 18 (1.1) 13 (0.9) Table 3B Adverse Events Reported in ≥1% of Fetuses or Neonates of Mothers Who Received Regional Anesthesia (Cesarean Section and Labor Studies) Adverse Reaction Naropin total N=639 Bupivacaine total N=573 N (%) N (%) Fetal bradycardia 77 (12.1) 68 (11.9) Neonatal jaundice 49 (7.7) 47 (8.2) Neonatal complication-NOS 42 (6.6) 38 (6.6) Apgar score low 18 (2.8) 14 (2.4) Neonatal respiratory disorder 17 (2.7) 18 (3.1) Neonatal tachypnea 14 (2.2) 15 (2.6) Neonatal fever 13 (2) 14 (2.4) Fetal tachycardia 13 (2) 12 (2.1) Fetal distress 11 (1.7) 10 (1.7) Neonatal infection 10 (1.6) 8 (1.4) Neonatal hypoglycemia 8 (1.3) 16 (2.8) Incidence 38.5°C. This occurred more frequently at doses of Naropin >16 mg/h. Neurologic Reactions These are characterized by excitation and/or depression. Restlessness, anxiety, dizziness, tinnitus, blurred vision or tremors may occur, possibly proceeding to convulsions. However, excitement may be transient or absent, with depression being the first manifestation of an adverse reaction. …

7 DRUG INTERACTIONS Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics [see Warnings and Precautions ( 5.4 )] : Examples of Drugs Associated with Methemoglobinemia Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants Phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine NAROPIN should be used with caution in patients receiving other local anesthetics or agents structurally related to amide- type local anesthetics, since the toxic effects of these drugs are additive. Cytochrome P4501A2 is involved in the formation of 3-hydroxy ropivacaine, the major metabolite. In vivo, the plasma clearance of ropivacaine was reduced by 70% during coadministration of fluvoxamine (25 mg bid for 2 days), a selective and potent CYP1A2 inhibitor. Thus strong inhibitors of cytochrome P4501A2, such as fluvoxamine, given concomitantly during administration of NAROPIN, can interact with NAROPIN leading to increased ropivacaine plasma levels. Caution should be exercised when CYP1A2 inhibitors are coadministered. Possible interactions with drugs known to be metabolized by CYP1A2 via competitive inhibition such as theophylline and imipramine may also occur. Coadministration of a selective and potent inhibitor of CYP3A4, ketoconazole (100 mg bid for 2 days with ropivacaine infusion administered 1 hour after ketoconazole) caused a 15% reduction in in vivo plasma clearance of ropivacaine. Specific trials studying the interaction between ropivacaine and class III antiarrhythmic drugs (e.g., amiodarone) have not been performed, but caution is advised [see Warnings and Precautions ( 5.13 )] . • Agents structurally related to amide-type local anesthetics: Concurrent use may cause additive effects. ( 7 )

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no available human data on use of Naropin (ropivacaine) Injection in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Local anesthetics may cause varying degrees of toxicity to the mother and fetus and adverse reactions include alterations of the central nervous system, peripheral vascular tone, and cardiac function (see Clinical Considerations ) . No teratogenicity was observed at doses up to 0.3 times the maximum recommended human dose of 770 mg/24 hours for epidural use, and equal to the MRHD of 250 mg for nerve block use, based on body surface area (BSA) comparisons and a 60 kg human weight (see Animal 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% to 4% and 15% to 20%, respectively. Clinical Considerations Labor or Delivery Local anesthetics, including ropivacaine, rapidly cross the placenta, and when used for epidural block can cause varying degrees of maternal, fetal, and neonatal toxicity [see Clinical Pharmacology ( 12 )] . The incidence and degree of toxicity depend upon the procedure performed, the type and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus and neonate involve alterations of the central nervous system, peripheral vascular tone and cardiac function. Maternal Adverse reactions Maternal hypotension has resulted from regional anesthesia. Local anesthetics produce vasodilation by blocking sympathetic nerves. Therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels be accomplished. Elevating the patient's legs will also help prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable. Data Animal data No malformations were reported in embryo-fetal development toxicity studies conducted in pregnant New Zealand white rabbits and Sprague-Dawley rats. During gestation days 6 to 18, rabbits received daily subcutaneous doses of ropivacaine at 1.3, 4.2, or 13 mg/kg/day (equivalent to 0.03, 0.10, and 0.33 times the maximum recommended human dose (MRHD) of 770 mg/24 hours, respectively, and 0.10, 0.32, and 1.0 times the MRHD of 250 mg for nerve block use, respectively based on body surface area (BSA) comparisons and a 60 kg human weight). Rats received daily subcutaneous doses of 5.3, 11, and 26 mg/kg/day (equivalent to 0.07, 0.14, and 0.33 times the MRHD for epidural use, respectively, and 0.21, 0.43, and 1.0 times the MRHD for nerve block use, respectively, based on BSA comparisons) during GD 6 to 15. No treatment-related effects on late fetal development, parturition, litter size, lactation, neonatal viability, or growth of the offspring were reported in a prenatal and postnatal reproductive and development toxicity study; however functional endpoints were not evaluated. Female rats were dosed daily subcutaneously from GD 15 to Lactation Day 20 at doses of 5.3, 11,and 26 mg/kg/day (equivalent to 0.07, 0.1, and 0.3 times the MRHD for epidural use, respectively, and 0.21, 0.43, and 1.0 times the MRHD for nerve block use, respectively), with maternal toxicity exhibited at the high dose. No adverse effects in physical developmental milestones or in behavioral tests were reported in a 2-generational reproduction study, in which rats received daily subcutaneous doses of 6.3, 12, and 23 mg/kg/day (equivalent to 0.08, 0.15, an …

12.1 Mechanism of Action Ropivacaine is a member of the amino amide class of local anesthetics and is supplied as the pure S-(-)-enantiomer. Local anesthetics block the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination and conduction velocity of affected nerve fibers. Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone.

11 DESCRIPTION NAROPIN ® Injection is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. NAROPIN ® Injection is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula: C 17 H 26 N 2 O•HCl•H 2 O M.W. 328.89 At 25 °C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n -octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. NAROPIN (ropivacaine hydrochloride) injection is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of NAROPIN Injection solutions range from 1.002 to 1.005 at 25°C. Structural Formula

10 OVERDOSAGE Acute emergencies from local anesthetics are generally related to high plasma levels encountered, or large doses administered, during therapeutic use of local anesthetics or to unintended subarachnoid or intravascular injection of local anesthetic solution [see Adverse Reactions ( 6 ) and Warnings and Precautions ( 5.1 , 5.2 , 5.6 )]. 10.1 Treatment Therapy with NAROPIN should be discontinued at the first sign of toxicity. No specific information is available for the treatment of toxicity with NAROPIN; therefore, treatment should be symptomatic and supportive. The first consideration is prevention, best accomplished by incremental injection of NAROPIN, careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness after each local anesthetic and during continuous infusion. At the first sign of change in mental status, oxygen should be administered. The first step in the management of systemic toxic reactions, as well as underventilation or apnea due to unintentional subarachnoid injection of drug solution, consists of immediate attention to the establishment and maintenance of a patent airway and effective assisted or controlled ventilation with 100% oxygen with a delivery system capable of permitting immediate positive airway pressure by mask. Circulation should be assisted as necessary. This may prevent convulsions if they have not already occurred. If necessary, use drugs to control convulsions. Intravenous barbiturates, anticonvulsant agents, or muscle relaxants should only be administered by those familiar with their use. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated. Supportive treatment of circulatory depression may require administration of intravenous fluids, and, when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine or epinephrine to enhance myocardial contractile force). Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome. The mean dosages of ropivacaine producing seizures, after intravenous infusion in dogs, nonpregnant and pregnant sheep were 4.9, 6.1 and 5.9 mg/kg, respectively. These doses were associated with peak arterial total plasma concentrations of 11.4, 4.3 and 5 mcg/mL, respectively. In human volunteers given intravenous NAROPIN, the mean (min-max) maximum tolerated total and free arterial plasma concentrations were 4.3 (3.4 to 5.3) and 0.6 (0.3 to 0.9) mcg/mL respectively, at which time moderate CNS symptoms (muscle twitching) were noted. Clinical data from patients experiencing local anesthetic induced convulsions demonstrated rapid development of hypoxia, hypercarbia and acidosis within a minute of the onset of convulsions. These observations suggest that oxygen consumption and carbon dioxide production are greatly increased during local anesthetic convulsions and emphasize the importance of immediate and effective ventilation with oxygen which may avoid cardiac arrest. If difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated, endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated after initial administration of oxygen by mask. The supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus. Therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels should be accomplished. Resuscitation of obstetrical patients may take longer than resuscitation of non- pregnant patients and closed-chest cardiac compression may be ineffective. Rapid delivery of the fetus may improve the response t …

16 HOW SUPPLIED/STORAGE AND HANDLING NAROPIN (ropivacaine hydrochloride) Injection is a clear colorless, and preservative-free solution, available in single-dose containers in 2 mg/mL (0.2%), 5 mg/mL (0.5%), 7.5 mg/mL (0.75%) and 10 mg/mL (1%) concentrations. Storage Solutions should be stored at 20oC to 25°C (68oF to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. NAROPIN® Single-Dose Vials Product Code Unit of Sale Strength Each 278513 NDC 63323-285-13 Unit of 25 0.2%, 20 mg per 10 mL (2 mg per mL) NDC 63323-285-03 10 mL Single-Dose Vial 278523 NDC 63323-285-23 Unit of 25 0.2%, 40 mg per 20 mL (2 mg per mL) NDC 63323-285-07 20 mL Single-Dose Vial 278623 NDC 63323-286-23 Unit of 25 0.5%,100 mg per 20 mL (5 mg per mL) NDC 63323-286-05 20 mL Single-Dose Vial 278630 NDC 63323-286-30 Packaged Individually 0.5%, 150 mg per 30 mL (5 mg per mL) NDC 63323-286-30 30 mL Single-Dose Vial 278631 NDC 63323-286-31 Unit of 5 0.5%, 150 mg per 30 mL (5 mg per mL) NDC 63323-286-09 30 mL Single-Dose Vial 278635 NDC 63323-286-35 Unit of 25 0.5%, 150 mg per 30 mL (5 mg per mL) NDC 63323-286-11 30 mL Single-Dose Vial 278721 NDC 63323-287-21 Unit of 25 0.75%, 150 mg per 20 mL (7.5 mg per mL) NDC 63323-287-03 20 mL Single-Dose Vial 278811 NDC 63323-288-11 Unit of 25 1%, 100 mg per 10 mL (10 mg per mL) NDC 63323-288-03 10 mL Single-Dose Vial 278821 NDC 63323-288-21 Unit of 25 1%, 200 mg per 20 mL (10 mg per mL) NDC 63323-288-07 20 mL Single-Dose Vial NAROPIN® Single-Dose Infusion Bottles Product Code Unit of Sale Strength Each 278565 NDC 63323-285-65 Individual bottles sold as a case of 12 0.2%, 200 mg per 100 mL (2 mg per mL) NDC 63323-285-51 100 mL Single-Dose Infusion Bottle 278564 NDC 63323-285-64 Individual bottles sold as a case of 12 0.2%, 400 mg per 200 mL (2 mg per mL) NDC 63323-285-57 200 mL Single-Dose Infusion Bottle 278600 NDC 63323-286-00 Unit of 12 0.5%, 500 mg per 100 mL (5 mg per mL) NDC 63323-286-03 100 mL Single-Dose Infusion Bottle 278663 NDC 63323-286-63 Unit of 12 0.5%, 1,000 mg per 200 mL (5 mg per mL) NDC 63323-286-33 200 mL Single-Dose Infusion Bottle For single-dose vials: Discard unused portion. NAROPIN container closure is not made with natural rubber latex. NAROPIN ® Single-Dose Plastic Polypropylene Ampule Sterile-Pak: Unit of 5 polypropylene ampules fitting both Luer-lock and Luer-slip (tapered syringes) Product Code Unit of Sale Strength Each 278510 NDC 63323-285-10 Unit of 5 0.2%, 20 mg per 10 mL (2 mg per mL) NDC 63323-285-01 10 mL Plastic Ampule 278520 NDC 63323-285-20 Unit of 5 0.2%, 40 mg per 20 mL (2 mg per mL) NDC 63323-285-06 20 mL Plastic Ampule 278620 NDC 63323-286-20 Unit of 5 0.5%, 100 mg per 20 mL (5 mg per mL) NDC 63323-286-01 20 mL Plastic Ampule 278720 NDC 63323-287-20 Unit of 5 0.75%, 150 mg per 20 mL (7.5 mg per mL) NDC 63323-287-01 20 mL Plastic Ampule 278810 NDC 63323-288-10 Unit of 5 1%, 100 mg per 10 mL (10 mg per mL) NDC 63323-288-01 10 mL Plastic Ampule 278820 NDC 63323-288-20 Unit of 5 1%, 200 mg per 20 mL (10 mg per mL) NDC 63323-288-06 20 mL Plastic Ampule NAROPIN ® single-dose, ready-to-use, polypropylene flexible bags. The flexible bag container is not made with natural rubber latex or polyvinyl chloride (PVC), Non-DEHP. Product Code Unit of Sale Strength Each 278561 NDC 63323-285-61 Unit of 24 0.2%, 200 mg per 100 mL (2 mg per mL) NDC 63323-285-02 100 mL Single-Dose, ready-to-use, polypropylene flexible bag 278563 NDC 63323-285-63 Unit of 24 0.2%, 400 mg per 200 mL (2 mg per mL) NDC 63323-285-04 250 mL Single-Dose, ready-to-use, polypropylene flexible bag NAROPIN container closure is not made with natural rubber latex. Single Dose Only - Discard unused portion.