Marcaine

Product NDC
0362-0557
11-digit product format
003620557
Labeler code
0362
Product ID
0362-0557_2095bcd0-0dc6-4b6e-a86c-23140421e3d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupivacaine hydrochloride and epinephrine bitartrate
Dosage form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Labeler
Septodont, Inc.
Application
ANDA077250
Marketing category
ANDA
Marketing start
2018-06-12
Substance
BUPIVACAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE
Active strength
5; .005 mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077250-001VIVACAINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-27

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MarcaineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATESeptodont, Inc.3e196aa4-0b01-44db-9267-98a995b547432025-10-10Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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 INSURING 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 insuff...

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

ADVERSE REACTIONS Reactions to Marcaine® 0.5% (5 mg/mL) with epinephrine 1:200,000 injection 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.

Additional Listing Data#

Finished product
Yes
Brand name base
Marcaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE ANHYDROUS5 mg/mL
EPINEPHRINE BITARTRATE.005 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAKA908P8J1, 30Q7KI53AK
Rxcui1670365, 1673142

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
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e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
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ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0362-0557-05Marcaine50 in 1 CARTONINJECTION, SOLUTION505
0362-0557-05Marcaine1.8 mL in 1 CARTRIDGEINJECTION, SOLUTION1.85

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0362-0557-05ML - Milliliter0362-0557129dbd53-583f-4c88-93e5-1712962900dd12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0362-0557MARCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]4Current NDC, Legacy NDC, 2 package rows20240217_3e196aa4-0b01-44db-9267-98a995b54743.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670365BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 1.8 ML Dental CartridgePSN3e196aa4-0b01-44db-9267-98a995b547435
1673142Marcaine 0.5 % / EPINEPHrine 1:200,000 in 1.8 ML Dental CartridgePSN3e196aa4-0b01-44db-9267-98a995b547435
16731421.8 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Cartridge [Marcaine with Epinephrine]SBD3e196aa4-0b01-44db-9267-98a995b547435
16703651.8 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML CartridgeSCD3e196aa4-0b01-44db-9267-98a995b547435
1670365bupivacaine HCl 0.5 % / epinephrine 1:200,000 per 1.8 ML Dental CartridgeSY3e196aa4-0b01-44db-9267-98a995b547435
1673142Marcaine 0.5 % / epinephrine (as bitartrate) 1:200,000 per 1.8 ML Dental CartridgeSY3e196aa4-0b01-44db-9267-98a995b547435

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0362-0557-050036205570550 CARTRIDGE in 1 CARTON (0362-0557-05) / 1.8 mL in 1 CARTRIDGE50 cartridge2018-06-120000-00-00NoNoCurrent