Marcaine 5 mg/mL
bupivacine hydrochloride · INJECTION, SOLUTION · Henry Schein, Inc.
Marcaine is a injection, solution containing bupivacine hydrochloride at 5 mg/mL, taken epidural. Manufactured by Henry Schein, Inc..
Key Facts
- Brand Name
- Marcaine
- Generic Name
- bupivacine hydrochloride
- NDC Code (Product)
0404-9768- Manufacturer
- Henry Schein, Inc.
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- EPIDURAL, INTRACAUDAL, PERINEURAL
- Marketing Status
- Application #
- NDA016964
- Marketing Start
- 01/26/2026
Recall History
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
Lack of sterility assurance.
Western Drug
Lack of Assurance of Sterility
Hospira Inc.
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Main Street Family Pharmacy, LLC
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
FVS Holdings, Inc. dba. Green Valley Drugs
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Hospira Inc.
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Main Street Family Pharmacy, LLC
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Hospira Inc., A Pfizer Company
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
Lack of sterility assurance.
Main Street Family Pharmacy, LLC
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Marcaine® 0.5% (5 mg/mL) with epinephrine 1:200,000 injection is indicated for the production of local anesthesia for dental procedures by infiltration injection or nerve block in adults. Marcaine® 0.5% (5 mg/mL) with epinephrine 1:200,000 injection is not recommended for children.
Dosage & Administration
DOSAGE AND ADMINISTRATION As with all 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 patien…
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 …
Contraindications
CONTRAINDICATIONS Marcaine® 0.5% (5 mg/mL) with epinephrine 1:200,000 injection, 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.
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. Marcaine® 0.5% (5 mg/mL) with epinephrine 1:200,000 injection 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.
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. Allerg…
Frequently Asked Questions
What is Marcaine used for?
Marcaine contains bupivacine hydrochloride. It is a injection, solution taken epidural. Consult your doctor for specific uses.
Is Marcaine a controlled substance?
Marcaine is not classified as a controlled substance by the DEA.
What is the generic name for Marcaine?
The generic name for Marcaine is bupivacine hydrochloride. There are no other listed brand versions of bupivacine hydrochloride.
What is the NDC code for Marcaine 5 mg/mL?
The NDC (National Drug Code) for Marcaine 5 mg/mL is 0404-9768, listed by Henry Schein, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)