Lidocaine Hydrochloride

1 INDICATIONS AND USAGE Lidocaine hydrochloride injection, USP is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of lidocaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)] . Lidocaine Hydrochloride Injection, USP contains lidocaine, an amide local anesthetic Lidocaine hydrochloride injection, USP is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. (1, 2.2) 1.1 Hypertension Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.

2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for recommended dosages and administration information for adult and pediatric patients 2.1 Important Dosage and Administration Information Lidocaine Hydrochloride Injection is not recommended for intrathecal use. Avoid use of Lidocaine Hydrochloride Injection solutions containing antimicrobial preservatives (i.e., multiple-dose vials) for epidural or caudal anesthesia [see Warnings and Precautions (5.3) ]. Discard unused portions of solution not containing preservatives, i.e., those supplied in single-dose vials, following initial use. Visually inspect this product for particulate matter and discoloration prior to administration whenever solution and container permit. Lidocaine Hydrochloride Injection is clear, colorless solution. Do not administer solutions which are discolored or contain particulate matter. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Solutions which are discolored (e.g., pinkish or darker than slightly yellow) or which contain particulate matter or precipitate should not be administered. Mixing or the prior or intercurrent use of any other local anesthetic with Lidocaine Hydrochloride Injection is not recommended because of insufficient data on the clinical use of such mixtures. Administration Precautions Lidocaine Hydrochloride Injection is to be administered in carefully adjusted dosages by or under the supervision of experienced clinicians who are well versed in the diagnosis and management of dose related toxicity and other acute emergencies which might arise from the block to be employed. Use Lidocaine Hydrochloride Injection only if the following are immediately available: oxygen, cardiopulmonary resuscitative equipment and drugs, and the personnel resources needed for proper management of toxic reactions and related emergencies [see Warnings and Precautions (5.1) , Adverse Reactions (6) , Overdosage (10)]. The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity when additional local anesthetics are administered with Lidocaine Hydrochloride Injection [see Warnings and Precautions (5.1) , Drug Interactions (7.1) , Overdosage (10) ]. Aspirate for blood or cerebrospinal fluid (where applicable) prior to injecting Lidocaine Hydrochloride Injection, both the initial dose and all subsequent doses, to avoid intravascular or intrathecal injection. However, a negative aspiration for blood or cerebrospinal fluid does not ensure against an intravascular or intrathecal injection [see Warnings and Precautions (5.7) ]. Avoid rapid injection of a large volume of Lidocaine Hydrochloride Injection and use fractional (incremental) doses when feasible. During major regional nerve blocks, such as those of the brachial plexus or lower extremity, the patient should have an indwelling intravenous catheter to assure adequate intravenous access. The lowest dosage of Lidocaine Hydrochloride Injection that results in effective anesthesia should be used to avoid high plasma levels and serious adverse reactions. Perform careful and constant monitoring of cardiovascular and respiratory (adequacy of oxygenation and ventilation) vital signs and the patient’s level of consciousness after each local anesthetic injection. Use Lidocaine Hydrochloride Injection in carefully restricted quantities in areas of the body supplied by end arteries or having otherwise compromised blood supply such as digits, nose, external ear, or penis [see Warnings and Precautions (5.10) ]. 2.2 Recommended Concentrations and Dosages of Lidocaine Hydrochloride Injection in Adults The dosage of Lidocaine Hydrochloride Injection 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 …

3 DOSAGE FORMS AND STRENGTHS Lidocaine Hydrochloride Injection, USP is a clear solution available as: • 0.5% (250 mg per 50 mL) (5 mg per mL), 50 mL single-dose teartop vials • 1% (20 mg per 2 mL) (10 mg per mL), 2 mL single-dose ampuls • 1% (50 mg per 5 mL) (10 mg per mL), 5 mL single-dose ampuls • 1% (300 mg per 30 mL) (10 mg per mL), 30 mL single-dose teartop vials • 1.5% (300 mg per 20 mL) (15 mg per mL), 20 mL single-dose ampuls • 2% (40 mg per 2 mL) (20 mg per mL), 2 mL single-dose ampuls • 2% (200 mg per 10 mL) (20 mg per mL), 10 mL single-dose ampuls • 0.5% (250 mg per 50 mL) (5 mg per mL), 50 mL multiple-dose fliptop vials • 1% (200 mg per 20 mL) (10 mg per mL), 20 mL multiple-dose fliptop vials • 1% (500 mg per 50 mL) (10 mg per mL), 50 mL multiple-dose fliptop vials • 2% (400 mg per 20 mL) (20 mg per mL), 20 mL multiple-dose fliptop vials • 2% (1000 mg per 50 mL) (20 mg per mL), 50 mL multiple-dose fliptop vials • Lidocaine Hydrochloride Injection, single-dose vials: 0.5%, 1% ( 3 ) • Lidocaine Hydrochloride Injection, single-dose ampuls: 1%, 1.5%, 2% ( 3 ) • Lidocaine Hydrochloride Injection, multiple-dose vials: 0.5%, 1%, 2% ( 3 )

CONTRAINDICATIONS Lidocaine hydrochloride is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. Lidocaine hydrochloride should not be used in patients with Stokes-Adams syndrome, Wolff-Parkinson-White syndrome or with severe degrees of sinoatrial, atrioventricular or intraventricular block in the absence of an artificial pacemaker.

ADVERSE REACTIONS Systemic Adverse experiences following the administration of lidocaine HCl are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption or inadvertent intravascular injection, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported: Central Nervous System CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following the administration of lidocaine HCl is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. Cardiovascular System Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest. Allergic Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity to local anesthetic agents. Allergic reactions, including anaphylactic reactions, may occur as a result of sensitivity to lidocaine, but are infrequent. If allergic reactions do occur, they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value. There have been no reports of cross sensitivity between lidocaine hydrochloride and procainamide or between lidocaine hydrochloride and quinidine. Neurologic The incidences of adverse reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon the particular drug used, the route of administration and the physical status of the patient. In a prospective review of 10,440 patients who received lidocaine HCl for spinal anesthesia, the incidences of adverse reactions were reported to be about 3 percent each for positional headaches, hypotension and backache; 2 percent for shivering; and less than 1 percent each for peripheral nerve symptoms, nausea, respiratory inadequacy and double vision. Many of these observations may be related to local anesthetic techniques, with or without a contribution from the local anesthetic. In the practice of caudal or lumbar epidural block, occasional unintentional penetration of the subarachnoid space by the catheter may occur. Subsequent adverse effects may depend partially on the amount of drug administered subdurally. These may include spinal block of varying magnitude (including total spinal block), hypotension secondary to spinal block, loss of bladder and bowel control, and loss of perineal sensation and sexual function. Persistent motor, sensory and/or autonomic (sphincter control) deficit of some lower spinal segments with slow recovery (several months) or incomplete recovery have been reported in rare instances when caudal or lumbar epidural block has been attempted. Backache and headache have also been noted following use of these anesthetic procedures. There have been reported cases of permanent injury to extraocular muscles requiring surgical repair following retrobulbar administration. Hematologic Methemoglobinemia.

Systemic Adverse experiences following the administration of lidocaine HCl are similar in nature to those observed with other amide local anesthetic agents. These adverse …

7 DRUG INTERACTIONS Local Anesthetics: The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects when additional local anesthetics are administered. (7.1) Monoamine Oxidase Inhibitors and Tricyclic Antidepressants: Administration of Lidocaine Hydrochloride Injection to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe, prolonged hypertension. Concurrent use of these agents should generally be avoided. ( 5.5, 7.2 ) Ergot-type Oxytocic drugs: Concurrent administration of Lidocaine Hydrochloride Injection and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. ( 5.5, 7.3 ) Nonselective Beta-Adrenergic Antagonists: Administration of Lidocaine Hydrochloride Injection in patients receiving nonselective beta-adrenergic antagonist may cause severe hypertension and bradycardia. Concurrent use of these agents should generally be avoided. ( 5.5 , 7.4) Drugs Associated with Methemoglobinemia: Patients are at increased risk of developing methemoglobinemia when concurrently exposed to nitrates, nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants and other drugs.( 7.5 ). Potent Inhalation Anesthetics: Serious dose-related cardiac arrhythmias may occur if preparations containing epinephrine are used in patients during or following the administration of potent inhalation anesthetics. ( 5.11 , 7.6 ) Geriatric Use: Elderly patients should be given reduced doses commensurate with their age and physical condition. ( 8.5 ) Hepatic Impairment: consider reduced dosing and increased monitoring for local anesthetic systemic toxicity in patients with hepatic impairment. ( 8.6 ) 7.1 Local Anesthetics The toxic effects of local anesthetics are additive. If coadministration of other local anesthetics with lidocaine hydrochloride cannot be avoided, monitor patients for neurologic and cardiovascular effects related to local anesthetic systemic toxicity [see Warnings and Precautions (5.1 )]. 7.2 Monoamine Oxidase Inhibitors and Tricyclic Antidepressants The administration of Lidocaine Hydrochloride Injection to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe, prolonged hypertension. Concurrent use of these agents should generally be avoided. In situation when concurrent therapy is necessary, careful monitoring of the patient’s hemodynamic status is essential [see Warnings and Precautions (5.5) ]. 7.3 Ergot-Type Oxytocic Drugs Concurrent administration of vasopressor drugs (for the treatment of hypotension related to obstetric blocks) and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. Avoid use of Lidocaine Hydrochloride Injection concomitantly with ergot-type oxytocic drugs [see Warnings and Precautions (5.5) ]. 7.4 Nonselective Beta-Adrenergic Antagonists Administration of Lidocaine Hydrochloride Injection in patients receiving nonselective beta-adrenergic antagonists may cause severe hypertension and bradycardia. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful monitoring of the patient’s blood pressure and heart rate is essential [see Warnings and Precautions (5.5) ]. 7.5 Drugs Associated with Methemoglobinemia Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents: Class Examples Nitrates/Nitrites nitroglycerin, nitroprusside, nitric oxide, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea Antibiotics dapsone, sulfonamides, nitrofurantoin, para- aminosalicylic acid Antimalarials chloroquine, primaquine Anticonvulsants phenytoin, …

8 USE IN SPECIFIC POPULATIONS • Geriatric Use : Elderly patients should be given reduced doses commensurate with their age and physical condition. ( 8.5 ) • Hepatic Impairment : Consider reduced dosing and increased monitoring for local anesthetic systemic toxicity in patients with hepatic impairment. ( 8.6 ) 8.1 Pregnancy Risk Summary Available published data and decades of clinical use with lidocaine hydrochloride in pregnant women have not identified any drug-associated risk for 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 ) . In a published animal reproduction study, pregnant rats administered lidocaine by continuous subcutaneous infusion at a dose approximately 9.6 times the maximum recommended human dose (MRHD) of 500 mg of lidocaine hydrochloride during the period of organogenesis resulted in lower fetal body weights [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 defects, loss, or other adverse outcomes. In the United States general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations 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. Labor or Delivery Local anesthetics rapidly cross the placenta, and when used for epidural, paracervical, pudendal or caudal block anesthesia, can cause varying degrees of maternal, fetal and neonatal toxicity [see Clinical Pharmacology (12.3) ] . 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. However, dosage recommendations for spinal anesthesia are much lower than dosage recommendations for other major blocks. Spinal anesthesia may alter the forces of parturition through changes in uterine contractility or maternal expulsive efforts. Spinal anesthesia has also been reported to prolong the second stage of labor by removing the parturient’s reflex urge to bear down or by interfering with motor function. The use of obstetrical anesthesia may increase the need for forceps assistance. The use of some local anesthetic drug products during labor and delivery may be followed by diminished muscle strength and tone for the first day or two of life. Data Animal Data Reproduction studies have been performed in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine hydrochloride. In a published study, lidocaine administered to pregnant rats by continuous subcutaneous infusion during the period of organogenesis at 100, 250, and 500 mg/kg/day, did not produce any structural abnormalities, but did result in lower fetal weights at 500 mg/kg/day dose (approximately 9.6 times the maximum recommended human dose [MRHD] of 500 mg lidocaine on a mg/m 2 basis) in the absence of maternal toxicity. 8.2 Lactation Risk Summa …

12.1 Mechanism of Action Lidocaine hydrochloride stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses thereby effecting local anesthetic action. Epinephrine is a vasoconstrictor added to lidocaine to slow absorption into the general circulation and thus prolong maintenance of an active tissue concentration.

11 DESCRIPTION Lidocaine hydrochloride injection, USP contains lidocaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for lidocaine hydrochloride injection, USP is by injection, for infiltration, nerve block, epidural and caudal use. Multiple dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Dosage forms listed as lidocaine hydrochloride injection, USP - MPF indicate single-dose solutions that are Methylparaben Free (MPF). Lidocaine hydrochloride, is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride monohydrate and has the molecular weight of 288.8 g/mol. Lidocaine hydrochloride molecular formula is C 14 H 22 N 2 O • HCl•H 2 O, and has the following structural formula: Lidocaine hydrochloride injection, USP in multiple dose vials is a sterile, nonpyrogenic, isotonic, clear, colorless solution containing lidocaine hydrochloride and sodium chloride. Each mL contains 1 mg methylparaben as an antiseptic preservative. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and hydrochloric acid. Ingredients Strength 1% 2% Amount (Per mL) Amount (Per mL) Lidocaine Hydrochloride (Anhydrous) 10 mg£ 20 mg μ Sodium Chloride 7 mg 6 mg Methylparaben 1 mg 1 mg Sodium Hydroxide Added for pH Adjustment to approximately 6.5 (5.0 to 7.0) Hydrochloric Acid £Quantity is equivalent to 10.7 mg/ mL Lidocaine Hydrochloride, USP (Monohydrate). μ Quantity is equivalent to 21.4 mg/ mL Lidocaine Hydrochloride, USP (Monohydrate). Lidocaine hydrochloride injection, USP -MPF is a sterile, nonpyrogenic, isotonic, clear, colorless, and preservative-free solution. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and hydrochloric acid. Ingredients Strength 1% 2% Amount (Per mL) Amount (Per mL) Lidocaine Hydrochloride (Anhydrous) 10 mg£ 20 mg μ Sodium Chloride 7 mg 6 mg Sodium Hydroxide Added for pH Adjustment to approximately 6.5 (5.0 to 7.0) Hydrochloric Acid £Quantity is equivalent to 10.7 mg/ mL Lidocaine Hydrochloride, USP (Monohydrate). μ Quantity is equivalent to 21.4 mg/ mL Lidocaine Hydrochloride, USP (Monohydrate). "Image Description"

OVERDOSAGE Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution (see ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS ). Management of Local Anesthetic Emergencies The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic injection. At the first sign of change, oxygen should be administered. The first step in the management of convulsions, as well as underventilation or apnea due to unintended subarachnoid injection of drug solution, consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to the use of local anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation (eg, ephedrine). If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. Underventilation or apnea due to unintentional subarachnoid injection of local anesthetic solution may produce these same signs and also lead to cardiac arrest if ventilatory support is not instituted. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted. Endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated, after initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated. Dialysis is of negligible value in the treatment of acute overdosage with lidocaine HCl. The oral LD 50 of lidocaine HCl in non-fasted female rats is 459 (346 to 773) mg/kg (as the salt) and 214 (159 to 324) mg/kg (as the salt) in fasted female rats.

Management of Local Anesthetic Emergencies The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic injection. At the first sign of change, oxygen should be administered. The first step in the management of convulsions, as well as underventilation or apnea due to unintended subarachnoid injection of drug solution, consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to the use of local …

HOW SUPPLIED Lidocaine Hydrochloride Injection, USP is supplied as follows: Unit of Sale Concentration Each Single-dose NDC 0409-4278-01 Tray of 25 0.5% 250 mg/50 mL (5 mg/mL) NDC 0409-4278-16 Glass Teartop Vial NDC 0409-4713-62 Case of 800 1% 20 mg/2 mL (10 mg/mL) NDC 0409-4713-72 Glass Ampul NDC 0409-4713-65 Case of 800 1% 50 mg/5 mL (10 mg/mL) NDC 0409-4713-75 Glass Ampul NDC 0409-4279-02 Carton of 25 1% 300 mg/30 mL (10 mg/mL) NDC 0409-4279-16 Glass Teartop Vial NDC 0409-4270-01 Case of 25 1% 300 mg/30 mL (10 mg/mL) NDC 0409-4270-11 Glass Teartop Vial NDC 0409-4776-01 Carton of 25 1.5% 300 mg/20 mL (15 mg/mL) NDC 0409-4776-10 Glass Ampul NDC 0409-4056-01 Carton of 5 1.5% 300 mg/20 mL (15 mg/mL) NDC 0409-4056-11 Glass Ampul NDC 0409-4282-02 Carton of 25 2% 200 mg/10 mL (20 mg/mL) NDC 0409-4282-12 Glass Ampul Unit of Sale Concentration Clam cell Each Single-dose NDC 0409-4713-02 5 clamcells per Carton 1% 50 mg/5 mL (10 mg/mL) NDC 0409-4713-26 5 ampuls per Clamcell NDC 0409-4713-12 Glass Ampul NDC 0409-4713-32 5 clamcells per Carton 1% 20 mg/2 mL (10 mg/mL) NDC 0409-4713-25 10 ampuls per Clamcell NDC 0409-4713-42 Glass Ampul NDC 0409-4282-01 5 clamcells per Bundle 2% 40 mg/2 mL (20mg/mL) NDC 0409-4282-25 5 ampuls per Clamcell NDC 0409-4282-11 Glass Ampul Unit of Sale Concentration Each Multiple-dose: NDC 0409-4275-01 Tray of 25 0.5% 250 mg/50 mL (5 mg/mL) NDC 0409-4275-16 Plastic Fliptop Vial NDC 0409-4276-01 Tray of 25 1% 200 mg/20 mL (10 mg/mL) NDC 0409-4276-16 Plastic Fliptop Vial NDC 0409-4276-02 Tray of 25 1% 500 mg/50 mL (10 mg/mL) NDC 0409-4276-17 Plastic Fliptop Vial NDC 0409-4277-01 Tray of 25 2% 400 mg/20 mL (20 mg/mL) NDC 0409-4277-16 Plastic Fliptop bottle NDC 0409-4277-02 Tray of 25 2% 1000 mg/50 mL (20 mg/mL) NDC 0409-4277-17 Plastic Fliptop Vial Single-dose products are preservative-free. Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature.] Lidocaine Hydrochloride Injection, USP solutions packaged in ampuls and glass teartop vials may be autoclaved one time only. Autoclave at 15 pounds pressure, 121°C (250°F) for 15 minutes. DO NOT AUTOCLAVE PRODUCT IN PLASTIC VIALS.