Label:
MARCAINE- bupivacaine hydrochloride injection, solution
MARCAINE WITH EPINEPHRINE- bupivacaine hydrochloride and epinephr...
view full title

  • NDC Code(s): 0409-0525-01, 0409-0525-25, 0409-1250-01, 0409-1250-25, view more
  • Packager: Hospira, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated May 27, 2025

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use MARCAINEâ„¢ and MARCAINEâ„¢ WITH EPINEPHRINE safely and effectively. See full prescribing information for MARCAINEâ„¢ and MARCAINEâ„¢ WITH ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: RISK OF CARDIAC ARREST WITH USE OF MARCAINE IN OBSTETRICAL ANESTHESIA

    There have been reports of cardiac arrest with difficult resuscitation or death during use of MARCAINE for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. Cardiac arrest has occurred after convulsions resulting from systemic toxicity, presumably following unintentional intravascular injection. The 0.75% (7.5 mg/mL) concentration of MARCAINE is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary [see Warnings and Precautions (5.1)].

    Close
  • 1 INDICATIONS AND USAGE
    MARCAINE / MARCAINE WITH EPINEPHRINE is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Dosage and Administration Information - • MARCAINE / MARCAINE WITH EPINEPHRINE is not for intrathecal use. • Avoid use of MARCAINE / MARCAINE WITH EPINEPHRINE solutions containing ...
  • 3 DOSAGE FORMS AND STRENGTHS
    MARCAINE (bupivacaine hydrochloride) injection is a clear, colorless solution available as: • 0.25% (25 mg/10 mL) (2.5 mg/mL) in single-dose vials. • 0.25% (75 mg/30 mL) (2.5 mg/mL) in ...
  • 4 CONTRAINDICATIONS
    MARCAINE / MARCAINE WITH EPINEPHRINE is contraindicated in: • obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. • intravenous ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Risk of Cardiac Arrest with Use of MARCAINE in Obstetrical Anesthesia - There have been reports of cardiac arrest with difficult resuscitation or death during use of MARCAINE for epidural ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions have been reported and described in the Warnings and Precautions section of the labeling: • Cardiac Arrest in Obstetrical Anesthesia [see ...
  • 7 DRUG INTERACTIONS
    7.1 Local Anesthetics - The toxic effects of local anesthetics are additive. If coadministration of other local anesthetics with MARCAINE / MARCAINE WITH EPINEPHRINE cannot be avoided, monitor ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - MARCAINE / MARCAINE WITH EPINEPHRINE is contraindicated for obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal ...
  • 10 OVERDOSAGE
    Clinical Presentation - Acute emergencies from use of MARCAINE / MARCAINE WITH EPINEPHRINE are generally related to high plasma levels encountered during therapeutic use or to unintended ...
  • 11 DESCRIPTION
    MARCAINE / MARCAINE WITH EPINEPHRINE contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for MARCAINE (without ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Bupivacaine blocks the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Long-term studies in animals to evaluate the carcinogenic potential of bupivacaine hydrochloride have not been ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] MARCAINE—Solutions of MARCAINE that do not contain ...
  • 17 PATIENT COUNSELING INFORMATION
    Allergic-Type Reactions - Assess if the patient has had allergic-type reactions to amide-type local anesthetics or to other formulation ingredients, such as the antimicrobial preservative ...
  • SPL UNCLASSIFIED SECTION
    This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com. For medical information about MARCAINE / MARCAINE WITH EPINEPHRINE, please ...
  • PRINCIPAL DISPLAY PANEL - 25 mg/10 mL Vial Label - 1559
    10 mL - Single-dose Vial - NDC 0409-1559-18 - Rx only - Preservative-Free - Marcaineâ„¢ 0.25% bupivacaine HCl injection, USP - 25 mg/10 mL (2.5 mg/mL) For INFILTRATION, NERVE BLOCK, CAUDAL - and EPIDURAL ...
  • PRINCIPAL DISPLAY PANEL - 25 mg/10 mL Vial Tray - 1559
    10 mL - Preservative-Free - 10 Single-dose Vials - Rx only - NDC 0409-1559-10 - Contains 10 of NDC 0409-1559-18 - Marcaineâ„¢ 0.25% bupivacaine HCl injection, USP - 25 mg/10 mL (2.5 mg/mL) For INFILTRATION ...
  • PRINCIPAL DISPLAY PANEL - 75 mg/30 mL Vial Label - 1559
    30 mL - SINGLE-DOSE VIAL– PRESERVATIVE FREE - NDC 0409-1559-19 - Rx only - Marcaine™ 0.25% bupivacaine HCl injection, USP - 75 mg/30 mL (2.5 mg/mL) For INFILTRATION, NERVE BLOCK, CAUDAL, and EPIDURAL ...
  • PRINCIPAL DISPLAY PANEL - 75 mg/30 mL Vial Carton - 1559
    30 mL - 10 SINGLE-DOSE VIALS–PRESERVATIVE FREE - Rx only - NDC 0409-1559-30 - Contains 10 of NDC 0409-1559-19 - Marcaine™ 0.25% bupivacaine HCl injection, USP - 75 mg/30 mL (2.5 mg/mL) For INFILTRATION ...
  • PRINCIPAL DISPLAY PANEL - 50 mg/10 mL Vial Label - 1560
    10 mL Single-dose Vial - NDC 0409-1560-18 - Rx only - Preservative-Free - Marcaineâ„¢ 0.5% bupivacaine HCl injection, USP - 50 mg/10 mL (5 mg/mL) For NERVE BLOCK, CAUDAL - and EPIDURAL ANESTHESIA - NOT FOR ...
  • PRINCIPAL DISPLAY PANEL - 50 mg/10 mL Vial Tray - 1560
    10 mL - Preservative-Free - 10 Single-dose Vials - Rx only - NDC 0409-1560-10 - Contains 10 of NDC 0409-1560-18 - Marcaineâ„¢ 0.5% bupivacaine HCl injection, USP - 50 mg/10 mL (5 mg/mL) For NERVE BLOCK ...
  • PRINCIPAL DISPLAY PANEL - 150 mg/30 mL Vial Label - 1560
    30 mL - SINGLE-DOSE VIAL– PRESERVATIVE FREE - NDC 0409-1560-19 - Rx only - Marcaine™ 0.5% bupivacaine HCl injection, USP - 150 mg/30 mL (5 mg/mL) for NERVE BLOCK, CAUDAL, and EPIDURAL ANESTHESIA - NOT FOR ...
  • PRINCIPAL DISPLAY PANEL - 150 mg/30 mL Vial Carton - 1560
    30 mL - 10 SINGLE-DOSE VIALS–PRESERVATIVE FREE - Rx only - NDC 0409-1560-29 - Contains 10 of NDC 0409-1560-19 - Marcaine™ 0.5% bupivacaine HCl injection, USP - 150 mg/30 mL (5 mg/mL) for NERVE BLOCK ...
  • PRINCIPAL DISPLAY PANEL - 75 mg/10 mL Vial Label - 1582
    10 mL - Single-dose Vial - NDC 0409-1582-18 - Rx only - Preservative-Free - Marcaineâ„¢ 0.75% bupivacaine HCl injection, USP - 75 mg/10 mL (7.5 mg/mL) EPIDURAL and RETROBULBAR ANESTHESIA USE - NOT FOR OBSTETRIC ...
  • PRINCIPAL DISPLAY PANEL - 75 mg/10 mL Vial Tray - 1582
    10 mL - 10 Single-dose Vials - NDC 0409-1582-10 - Contains 10 of NDC 0409-1582-18 - Rx only - Preservative-Free - Marcaineâ„¢ 0.75% bupivacaine HCl injection, USP - 75 mg/10 mL (7.5 mg/mL) EPIDURAL and ...
  • PRINCIPAL DISPLAY PANEL - 225 mg/30 mL Vial Label - 1582
    30 mL - SINGLE-DOSE VIAL– PRESERVATIVE FREE - NDC 0409-1582-19 - Rx only - Marcaine™ 0.75% bupivacaine HCl injection, USP - 225 mg/30 mL (7.5 mg/mL) for EPIDURAL and RETROBULBAR ANESTHESIA - NOT FOR OBSTETRIC ...
  • PRINCIPAL DISPLAY PANEL - 225 mg/30 mL Vial Carton - 1582
    30 mL - 10 SINGLE-DOSE VIALS–PRESERVATIVE FREE - NDC 0409-1582-29 - Contains 10 of NDC 0409-1582-19 - Rx only - Marcaine™ 0.75% bupivacaine HCl injection, USP - 225 mg/30 mL (7.5 mg/mL) for EPIDURAL and ...
  • PRINCIPAL DISPLAY PANEL - 125 mg/50 mL Vial Label - 1587
    50 mL Multiple-Dose vial - Marcaineâ„¢ 0.25% bupivacaine HCl injection, USP - 125 mg/50 mL - (2.5 mg/mL) Each mL contains 2.5 mg bupivacaine - HCl, with 1 mg methylparaben as - antiseptic preservative and ...
  • PRINCIPAL DISPLAY PANEL - 125 mg/50 mL Vial Carton - 1587
    NDC 0409-1587-50 - Rx only - 50 mL Multiple-Dose Vial - Marcaineâ„¢ 0.25% bupivacaine HCl injection, USP - 125 mg/50 mL - (2.5 mg/mL) For INFILTRATION - and NERVE BLOCK - Not for caudal, epidural, or ...
  • PRINCIPAL DISPLAY PANEL - 250 mg/50 mL Vial Label - 1610
    50 mL Multiple-Dose Vial - Marcaineâ„¢ 0.5% bupivacaine HCl injection, USP - 250 mg/50 mL - (5 mg/mL) Each mL contains 5 mg bupivacaine HCl, with 1 mg methylparaben as antiseptic - preservative and NaCl ...
  • PRINCIPAL DISPLAY PANEL - 250 mg/50 mL Vial Carton - 1610
    NDC 0409-1610-50 - Rx only - 50 mL Multiple-Dose Vial - Marcaineâ„¢ 0.5% bupivacaine HCl injection, USP - 250 mg/50 mL - (5 mg/mL) for NERVE BLOCK - Not for caudal, epidural, or intrathecal ...
  • PRINCIPAL DISPLAY PANEL - 25 mg/10 mL Vial Label - 1746
    Preservative-Free - 10 mL Single-dose Vial - Marcaineâ„¢ 0.25% 25 mg/10 mL (2.5 mg/mL) with epinephrine 1:200,000 (as bitartrate) bupivacaine hydrochloride - and epinephrine injection, USP - For ...
  • PRINCIPAL DISPLAY PANEL - 25 mg/10 mL Vial Carton - 1746
    10 mL 10 Single-dose Vials - Preservative-Free - NDC 0409-1746-10 - Contains 10 of NDC 0409-1746-70 - Rx only - Marcaineâ„¢ 0.25% 25 mg/10 mL (2.5 mg/mL) with epinephrine 1:200,000 (as bitartrate) bupivacaine ...
  • PRINCIPAL DISPLAY PANEL - 75 mg/30 mL Vial Label - 1746
    30 mL Single Dose Vial - NDC 0409-1746-71 - Rx only - PRESERVATIVE-FREE - Marcaineâ„¢ 0.25% 75 mg/30 mL (2.5 mg/mL) with epinephrine 1:200,000 (as bitartrate) bupivacaine hydrochloride and epinephrine ...
  • PRINCIPAL DISPLAY PANEL - 75 mg/30 mL Vial Carton - 1746
    30 mL 10 Single Dose Vials - NDC 0409-1746-30 - Contains 10 of NDC 0409-1746-71 - Rx only - PRESERVATIVE-FREE - Marcaineâ„¢ 0.25% 75 mg/30 mL (2.5 mg/mL) with epinephrine 1:200,000 (as bitartrate) bupivacaine ...
  • PRINCIPAL DISPLAY PANEL - 50 mg/10 mL Vial Label - 1749
    10 mL Single-dose Vial - Preservative-Free - Marcaineâ„¢ 0.5% 50 mg/10 mL (5 mg/mL) with epinephrine 1:200,000 (as bitartrate) bupivacaine hydrochloride - and epinephrine injection, USP - For NERVE BLOCK ...
  • PRINCIPAL DISPLAY PANEL - 50 mg/10 mL Vial Carton - 1749
    10 mL 10 Single-dose Vials - NDC 0409-1749-10 - Contains 10 of NDC 0409-1749-70 - Rx only - Preservative-Free - Marcaineâ„¢ 0.5% 50 mg/10 mL (5 mg/mL) with epinephrine 1:200,000 (as bitartrate) bupivacaine ...
  • PRINCIPAL DISPLAY PANEL - 150 mg/30 mL Vial Label - 1749
    30 mL - Single Dose Vial - NDC 0409-1749-71 - Rx only - PRESERVATIVE-FREE - Marcaineâ„¢ 0.5% 150 mg/30 mL (5 mg/mL) with epinephrine 1:200,000 (as bitartrate) bupivacaine hydrochloride and epinephrine ...
  • PRINCIPAL DISPLAY PANEL - 150 mg/30 mL Vial Carton - 1749
    30 mL 10 Single Dose Vials - NDC 0409-1749-29 - Contains 10 of NDC 0409-1749-71 - Rx only - PRESERVATIVE-FREE - Marcaineâ„¢ 0.5% 150 mg/30 mL (5 mg/mL) with epinephrine 1:200,000 (as bitartrate) bupivacaine ...
  • PRINCIPAL DISPLAY PANEL - 125 mg/50 mL Vial Label - 1752
    50 mL Multiple-Dose Vial - NDC 0409-1752-50 - Rx only - Marcaineâ„¢ 0.25% 125 mg/50 mL (2.5 mg/mL) with epinephrine 1:200,000 (as bitartrate) bupivacaine hydrochloride and - epinephrine injection, USP ...
  • PRINCIPAL DISPLAY PANEL - 125 mg/50 mL Vial Carton - 1752
    NDC 0409-1752-50 - Rx only - 50 mL Multiple-Dose Vial - Marcaineâ„¢ 0.25% 125 mg/50 mL - (2.5 mg/mL) with epinephrine 1:200,000 - (as bitartrate) bupivacaine hydrochloride and - epinephrine injection ...
  • PRINCIPAL DISPLAY PANEL - 250 mg/50 mL Vial Label - 1755
    50 mL Multiple-Dose Vial - NDC 0409-1755-50 - Rx only - Marcaineâ„¢ 0.5% 250 mg/50 mL (5 mg/mL) with epinephrine 1:200,000 (as bitartrate) bupivacaine hydrochloride and - epinephrine injection, USP - for ...
  • PRINCIPAL DISPLAY PANEL - 250 mg/50 mL Vial Carton - 1755
    NDC 0409-1755-50 - Rx only - 50 mL Multiple-Dose Vial - Marcaineâ„¢ 0.5% 250 mg/50 mL - (5 mg/mL) with epinephrine 1:200,000 - (as bitartrate) bupivacaine hydrochloride and - epinephrine injection, USP - for ...
  • PRINCIPAL DISPLAY PANEL - 25 mg/10 mL Vial Label - 2510
    10 mL - Preservative-Free - Single-dose Vial - NDC 0409-2510-01 - Rx only - Marcaineâ„¢ 0.25% bupivacaine HCl injection, USP - 25 mg/10 mL (2.5 mg/mL) For INFILTRATION, NERVE BLOCK, CAUDAL - and EPIDURAL ...
  • PRINCIPAL DISPLAY PANEL - 25 mg/10 mL Vial Tray - 2510
    10 mL - Preservative-Free - 25 Single-dose Vials - NDC 0409-2510-25 - Contains 25 of NDC 0409-2510-01 - Rx only - Marcaineâ„¢ 0.25% bupivacaine HCl injection, USP - 25 mg/10 mL (2.5 mg/mL) For INFILTRATION ...
  • PRINCIPAL DISPLAY PANEL - 75 mg/30 mL Vial Label - 7535
    30 mL - SINGLE-DOSE VIAL– PRESERVATIVE FREE - NDC 0409-7535-01 - Rx only - Marcaine™ 0.25% bupivacaine HCl injection, USP - 75 mg/30 mL (2.5 mg/mL) For INFILTRATION, NERVE BLOCK, CAUDAL, and EPIDURAL ...
  • PRINCIPAL DISPLAY PANEL - 75 mg/30 mL Vial Tray - 7535
    30 mL - 25 SINGLE-DOSE VIALS–PRESERVATIVE FREE - NDC 0409-7535-25 - Contains 25 of NDC 0409-7535-01 - Rx only - Marcaine™ 0.25% bupivacaine HCl injection, USP - 75 mg/30 mL (2.5 mg/mL) For INFILTRATION ...
  • PRINCIPAL DISPLAY PANEL - 125 mg/50 mL Vial Label - 1250
    50 mL Multiple-Dose Vial - NDC 0409-1250-01 - Rx only - Marcaineâ„¢ 0.25% bupivacaine HCl injection, USP - 125 mg/50 mL - (2.5 mg/mL) Each mL contains 2.5 mg bupivacaine - HCl, with 1 mg methylparaben ...
  • PRINCIPAL DISPLAY PANEL - 125 mg/50 mL Vial Tray - 1250
    50 mL Multiple-Dose Vial - Rx only - NDC 0409-1250-25 - Contains 25 of NDC 0409-1250-01 - Marcaineâ„¢ 0.25% bupivacaine HCl injection, USP - 125 mg/50 mL (2.5 mg/mL) For INFILTRATION - and NERVE BLOCK - Not for ...
  • PRINCIPAL DISPLAY PANEL - 50 mg/10 mL Vial Label - 5010
    10 mL Preservative-Free - Single-dose Vial - NDC 0409-5010-01 - Rx only - Marcaineâ„¢ 0.5% bupivacaine HCl injection, USP - 50 mg/10 mL (5 mg/mL) For NERVE BLOCK, CAUDAL - and EPIDURAL ANESTHESIA - NOT FOR ...
  • PRINCIPAL DISPLAY PANEL - 50 mg/10 mL Vial Tray - 5010
    10 mL - Preservative-Free - 25 Single-dose Vials - NDC 0409-5010-25 - Contains 25 of NDC 0409-5010-01 - Rx only - Marcaineâ„¢ 0.5% bupivacaine HCl injection, USP - 50 mg/10 mL (5 mg/mL) For NERVE BLOCK ...
  • PRINCIPAL DISPLAY PANEL - 150 mg/30 mL Vial Label - 1530
    30 mL - SINGLE-DOSE VIAL– PRESERVATIVE FREE - NDC 0409-1530-01 - Rx only - Marcaine™ 0.5% bupivacaine HCl injection, USP - 150 mg/30 mL (5 mg/mL) for NERVE BLOCK, CAUDAL, and EPIDURAL ANESTHESIA - NOT FOR ...
  • PRINCIPAL DISPLAY PANEL - 150 mg/30 mL Vial Tray - 1530
    30 mL - 25 Single-dose Vials – Preservative Free - NDC 0409-1530-25 - Contains 25 of NDC 0409-1530-01 - Rx only - Marcaine™ 0.5% bupivacaine HCl injection, USP - 150 mg/30 mL (5 mg/mL) for NERVE BLOCK ...
  • PRINCIPAL DISPLAY PANEL - 250 mg/50 mL Vial Label - 0525
    50 mL Multiple-Dose Vial - NDC 0409-0525-01 - Rx only - Marcaineâ„¢ 0.5% bupivacaine HCl injection, USP - 250 mg/50 mL - (5 mg/mL) Each mL contains 5 mg bupivacaine HCl, with 1 mg methylparaben as ...
  • PRINCIPAL DISPLAY PANEL - 250 mg/50 mL Vial Tray - 0525
    50 mL Multiple-Dose Vial - Rx only - NDC 0409-0525-25 - Contains 25 of NDC 0409-0525-01 - Marcaineâ„¢ 0.5% bupivacaine HCl injection, USP - 250 mg/50 mL (5 mg/mL) For NERVE BLOCK - Not for caudal, epidural ...
  • PRINCIPAL DISPLAY PANEL - 75 mg/10 mL Vial Label - 7510
    10 mL - Single-dose Vial - Preservative-Free - NDC 0409-7510-01 - Rx only - Marcaineâ„¢ 0.75% bupivacaine HCl injection, USP - 75 mg/10 mL (7.5 mg/mL) EPIDURAL and RETROBULBAR ANESTHESIA USE - NOT FOR OBSTETRIC ...
  • PRINCIPAL DISPLAY PANEL - 75 mg/10 mL Vial Tray - 7510
    10 mL - Preservative-Free - 25 Single-dose Vials - NDC 0409-7510-25 - Contains 25 of NDC 0409-7510-01 - Rx only - Marcaineâ„¢ 0.75% bupivacaine HCl injection, USP - 75 mg/10 mL (7.5 mg/mL) EPIDURAL and ...
  • PRINCIPAL DISPLAY PANEL - 225 mg/30 mL Vial Label - 2253
    30 mL - SINGLE-DOSE VIAL– PRESERVATIVE FREE - NDC 0409-2253-01 - Rx only - Marcaine™ 0.75% bupivacaine HCl injection, USP - 225 mg/30 mL (7.5 mg/mL) for EPIDURAL and RETROBULBAR ANESTHESIA - NOT FOR OBSTETRIC ...
  • PRINCIPAL DISPLAY PANEL - 225 mg/30 mL Vial Tray - 2253
    30 mL - 25 SINGLE-DOSE VIALS–PRESERVATIVE FREE - NDC 0409-2253-25 - Contains 25 of NDC 0409-2253-01 - Rx only - Marcaine™ 0.75% bupivacaine HCl injection, USP - 225 mg/30 mL (7.5 mg/mL) for EPIDURAL and ...
  • INGREDIENTS AND APPEARANCE
    Product Information