Vivacaine bupivacaine hydrochloride and epinephrine bitartrate 5 mg/mL; .005 mg/mL Injection, Solution, 50 cartridges
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Amide Local Anesthetic class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
- This injection is a long-acting local anesthetic used to numb a specific part of your body during a procedure — things like surgery, dental work, or certain diagnostic tests. Your...
- What is this injection actually for — why did my doctor order it?
- That depends on where and how the injection is given, but bupivacaine is known for being one of the longest-acting local anesthetics available. For dental injections, numbness can...
- How long will the numbness last, and what will it feel like wearing off?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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2 mg / 1 mL
UNII PQ6CK8PD0R
Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
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0.1 mg / 1 mL
UNII 25IH6R4SGF
Edetate calcium disodium is a chelating agent, a chemical that binds to metal ions. It's used in some medications to prevent unwanted metals from interfering with the drug's stability and effectiveness.
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0.001 mL / 1 mL
UNII AAO1P0WSXJ
Monothioglycerol is a clear liquid derived from glycerin with a sulfur-containing group added. It works as an antioxidant and reducing agent in medicines, helping prevent degradation of active ingredients during storage.
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7 mg / 1 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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0.0017 mL / 1 mL
UNII TU7HW0W0QT
A salt derived from lactic acid, sodium lactate acts as a buffer and pH stabilizer in medicines. It helps maintain the product's acidity level and can also serve as a humectant to retain moisture.
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0.5 mg / 1 mL
UNII 4VON5FNS3C
Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Marcaine 5 mg/mL; .005 mg/mL 00362-0557-05 | Septodont, | 50 cartridges | — | — | FDA listed | — |
| Vivacaine 5 mg/mL; .005 mg/mLthis 00362-9011-50 | Septodont, | 50 cartridges | — | — | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00362-9011-50 You're viewing this | 50 CARTRIDGE in 1 CARTON (0362-9011-50) / 1.8 mL in 1 CARTRIDGE | 2013-06-01 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Vivacaine® (bupivacaine hydrochloride and epinephrine injection, USP) is indicated for the production of local anesthesia for dental procedures by infiltration injection or nerve block in adults. Vivacaine® is not recommended for children.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION As with all local anesthetics, the dosage varies and depends upon the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. For specific techniques and procedures, refer to standard textbooks.
The 0.5% concentration with epinephrine is recommended for infiltration and block injection in the maxillary and mandibular area when a longer duration of local anesthetic action is desired, such as for oral surgical procedures generally associated with significant postoperative pain. The average dose of 1.8 mL (9 mg) per injection site will usually suffice; an occasional second dose of 1.8 mL (9 mg) may be used if necessary to produce adequate anesthesia after making allowance for 2 to 10 minutes onset time (see CLINICAL PHARMACOLOGY ).
The lowest effective dose should be employed and time should be allowed between injections; it is recommended that the total dose for all injection sites, spread out over a single dental sitting, should not ordinarily exceed 90 mg for a healthy adult patient (ten 1.8 mL injections of bupivacaine with epinephrine). Injections should be made slowly and with frequent aspirations. Until further experience is gained, bupivacaine in dentistry is not recommended for children younger than 12 years.
Parental drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard unused portion.
⛔ Contraindications ▾
CONTRAINDICATIONS Vivacaine® (bupivacaine hydrochloride and epinephrine injection, USP) is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide type or to other components of bupivacaine solutions.
⚠️ Warnings ▾
WARNINGS LOCAL ANESTHETICS SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES WHICH MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED, AND THEN ONLY AFTER ENSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY RESUSCITATIVE EQUIPMENT, AND THE PERSONNEL RESOURCES NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES. (See also ADVERSE REACTIONS and PRECAUTIONS .) DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION FROM ANY CAUSE, AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST AND, POSSIBLY, DEATH.
Small doses of local anesthetics injected into the head and neck area, as small as nine to eighteen milligrams, may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. Confusion, convulsions, respiratory depression, and/or respiratory arrest, cardiovascular stimulation or depression and cardiac arrest have been reported. Reactions resulting in fatalities have occurred on rare occasions.
In a few cases, resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation. Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed.
Resuscitative equipment and personnel for treating adverse reactions should be immediately available. Dosage recommendations should not be exceeded (see DOSAGE AND ADMINISTRATION ). It is essential that aspiration for blood or cerebrospinal fluid (where applicable) be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular injection.
However, a negative aspiration does not ensure against an intravascular injection. Reactions resulting in fatality have occurred on rare occasions with the use of local anesthetics, even in the absence of a history of hypersensitivity. This solution, which contains a vasoconstrictor, should be used with extreme caution for patients whose medical history and physical evaluation suggest the existence of hypertension, arteriosclerotic heart disease, cerebral vascular insufficiency, heart block, thyrotoxicosis and diabetes, etc., as well as patients receiving drugs likely to produce alterations in blood pressure.
Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.
Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue Vivacaine® and any other oxidizing agents.
Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. Bupivacaine with epinephrine 1:200,000 or other vasopressors should not be used concomitantly with ergot-type oxytocic drugs, because a severe persis…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Reactions to Vivacaine® (bupivacaine hydrochloride and epinephrine injection, USP) are characteristic of those associated with other amide-type local anesthetics. A major cause of adverse reactions to this group of drugs is excessive plasma levels, which may be due to overdosage, inadvertent intravascular injection or slow metabolic degradation. Excessive plasma levels of the amide-type local anesthetics cause systemic reactions involving the central nervous system and the cardiovascular system.
The central nervous system effects are characterized by excitation or depression. The first manifestation may be nervousness, dizziness, blurred vision, or tremors, followed by drowsiness, convulsions, unconsciousness, and possibly respiratory arrest. Since excitement may be transient or absent, the first manifestation may be drowsiness, sometimes merging into unconsciousness and respiratory arrest.
Other central nervous system effects may be nausea, vomiting, chills, constriction of the pupils, or tinnitus. The cardiovascular manifestations of excessive plasma levels may include depression of the myocardium, blood pressure changes (usually hypotension), and cardiac arrest. Allergic reactions, which may be due to hypersensitivity, idiosyncrasy, or diminished tolerance, are characterized by cutaneous lesions (e.g., urticaria), edema, and other manifestations of allergy.
Detection of sensitivity by skin testing is of doubtful value. Transient facial swelling and puffiness may occur near the injection site. Treatment of Reactions Toxic effects of local anesthetics require symptomatic treatment; there is no specific cure.
The dentist should be prepared to maintain an airway and to support ventilation with oxygen and assisted or controlled respiration as required. Supportive treatment of the cardiovascular system includes intravenous fluids and, when appropriate, vasopressors (preferably those that stimulate the myocardium). Convulsions may be controlled with oxygen and intravenous administration, in small increments, of a barbiturate, as follows: preferably, an ultra-short-acting barbiturate such as thiopental or thiamylal; if this is not available, a short-acting barbiturate (e.g., secobarbital or pentobarbital) or diazepam.
Intravenous barbiturates or anticonvulsant agents should only be administered by those familiar with their use.
🔄 Drug Interactions ▾
Drug Interactions See WARNINGS concerning solutions containing a vasoconstrictor. If sedatives are employed to reduce patient apprehension, use reduced doses, since local anesthetic agents, like sedatives, are central nervous system depressants which in combination may have an additive effect. Vivacaine® (bupivacaine hydrochloride and epinephrine injection, USP) should be used cautiously in persons with known drug allergies or sensitivities, particularly to the amide-type local anesthetics.
Serious dose-related cardiac arrhythmias may occur if preparations containing a vasoconstrictor such as epinephrine are employed in patients during or following the administration of chloroform, halothane, cyclopropane, trichloroethylene, or other related agents. In deciding whether to use these products concurrently in the same patient, the combined action of both agents upon the myocardium, the concentration and volume of vasoconstrictor used, and the time since injection, when applicable, should be taken into account.
🤰 Pregnancy ▾
Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Bupivacaine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Bupivacaine hydrochloride produced development toxicity when administered subcutaneously to pregnant rats and rabbits at clinically relevant doses.
This does not exclude the use of bupivacaine at term for obstetrical anesthesia or analgesia. Bupivacaine hydrochloride was administered subcutaneously to rats at doses of 4.4, 13.3, and 40 mg/kg and to rabbits at doses of 1.3, 5.8, and 22.2 mg/kg during the period of organogenesis (implantation to closure of the hard palate). The high doses are approximately 4-times the daily maximum recommended human dose (MRHD) of 90 mg/day on a mg dose/m2 body surface area (BSA) basis.
No embryo-fetal effects were observed in rats at the high dose which caused increased maternal lethality. An increase in embryo-fetal deaths was observed in rabbits at the high dose in the absence of maternal toxicity with the fetal No Observed Adverse Effect Level being a comparable dose to the MRHD on a BSA basis. In a rat pre- and post-natal development study (dosing from implantation through weaning) conducted at subcutaneous doses of 4.4, 13.3 and 40 mg/kg mg/kg/day, decreased pup survival was observed at the high dose.
The high dose is approximately 4-time the daily MRHD of 90 mg/day on a BSA basis.
🧒 Pediatric Use ▾
Pediatric Use Until further experience is gained in children younger than 12 years, administration of bupivacaine in this age group is not recommended.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Bupivacaine stabilizes the neuronal membrane and prevents the initiation and transmission of nerve impulses, thereby effecting local anesthesia. The onset of action following dental injections is usually 2 to 10 minutes and anesthesia may last two or three times longer than lidocaine and mepivacaine for dental use, in many patients up to 7 hours. The duration of anesthetic effect is prolonged by the addition of epinephrine 1:200,000.
It has also been noted that there is a period of analgesia that persists after the return of sensation, during which time the need for strong analgesic is reduced. After injection of bupivacaine for caudal, epidural or peripheral nerve block in man, peak levels of bupivacaine in the blood are reached in 30 to 45 minutes, followed by a decline to insignificant levels during the next three to six hours. Because of its amide structure, bupivacaine is not detoxified by plasma esterases but is detoxified, via conjugation with glucuronic acid, in the liver.
When administered in recommended doses and concentrations, bupivacaine does not ordinarily produce irritation or tissue damage. Systemic absorption of local anesthetics produces effects on the cardiovascular and central nervous systems (CNS). At blood concentrations achieved with normal therapeutic doses, changes in cardiac conduction, excitability, refractoriness, contractility, and peripheral vascular resistance are minimal.
However, toxic blood concentrations depress cardiac conduction and excitability, which may lead to atrioventricular block, ventricular arrhythmias, and cardiac arrest, sometimes resulting in fatalities. In addition, myocardial contractility is depressed and peripheral vasodilation occurs, leading to decreased cardiac output and arterial blood pressure. Recent clinical reports and animal research suggest that these cardiovascular changes are more likely to occur after unintended intravascular injection of bupivacaine.
Therefore, incremental dosing is necessary. Following systemic absorption, local anesthetics can produce central nervous system stimulation, depression, or both. Apparent central stimulation is manifested as restlessness, tremors and shivering progressing to convulsions, followed by depression and coma progressing ultimately to respiratory arrest.
However, the local anesthetics have a primary depressant effect on the medulla and on higher centers. The depressed stage may occur without a prior excited state.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Protect from light. Do not permit to freeze.
Vivacaine® (bupivacaine hydrochloride and epinephrine injection, USP) – Sterile isotonic solutions containing sodium chloride. Each 1 mL contains 5 mg bupivacaine hydrochloride and 0.0091 mg epinephrine bitartrate, with 0.5 mg sodium metabisulfite, 7 mg sodium chloride, 0.001 mL monothioglycerol, and 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate buffer, and 0.1 mg edetate calcium disodium as stabilizer. The pH of these solutions is adjusted with sodium hydroxide or hydrochloric acid.
Solutions of bupivacaine that contain epinephrine should not be autoclaved and should be protected from light. Do not use the solution if its colour is pinkish or darker than slightly yellow or if it contains a precipitate. Vivacaine® (NDC 0362-9011-50) is available in cardboard boxes containing 5 blisters of 10 X 1.8 mL single-dose dental cartridges.
📦 Storage and Handling ▾
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Protect from light. Do not permit to freeze.
Vivacaine® (bupivacaine hydrochloride and epinephrine injection, USP) – Sterile isotonic solutions containing sodium chloride. Each 1 mL contains 5 mg bupivacaine hydrochloride and 0.0091 mg epinephrine bitartrate, with 0.5 mg sodium metabisulfite, 7 mg sodium chloride, 0.001 mL monothioglycerol, and 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate buffer, and 0.1 mg edetate calcium disodium as stabilizer. The pH of these solutions is adjusted with sodium hydroxide or hydrochloric acid.
Solutions of bupivacaine that contain epinephrine should not be autoclaved and should be protected from light. Do not use the solution if its colour is pinkish or darker than slightly yellow or if it contains a precipitate. Vivacaine® (NDC 0362-9011-50) is available in cardboard boxes containing 5 blisters of 10 X 1.8 mL single-dose dental cartridges.
📋 Description ▾
DESCRIPTION Bupivacaine hydrochloride is (±) -1-Butyl-2´, 6´-pipecoloxylidide monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula: Molecular Weight - 342.90 C 18 H 28 N 2 O • HCl • H 2 O Epinephrine bitartrate is (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt. It has the following structural formula: Molecular Weight - 333.29 C 13 H 19 NO 9 Bupivacaine is available in a sterile isotonic solution with epinephrine 1:200,000 (as bitartrate).
Solutions of bupivacaine containing epinephrine may not be autoclaved. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine.
All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Chemical Structure Chemical Structure
💬 Information for Patients ▾
Information for Patients/Patient Counseling Information: When appropriate, the dentist should discuss information including adverse reactions in the package insert for Vivacaine®. Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.