FDA.reportPublic FDA data

Application 016964

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MARCAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.25%YesYes
004MARCAINE HYDROCHLORIDE W/ EPINEPHRINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEINJECTABLE;INJECTION0.25%;0.0091MG/MLYesYes
005MARCAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.5%YesYes
006MARCAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.5%YesYes
007MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEINJECTABLE;INJECTION0.5%;0.0091MG/MLYesYes
008MARCAINE HYDROCHLORIDE W/ EPINEPHRINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEINJECTABLE;INJECTION0.5%;0.0091MG/MLYesYes
009MARCAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.75%YesYes
010MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEINJECTABLE;INJECTION0.75%;0.0091MG/MLYesYes
012MARCAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.25%YesYes
013MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEINJECTABLE;INJECTION0.25%;0.0091MG/MLYesYes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N016964-001MARCAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016964-004MARCAINE HYDROCHLORIDE W/ EPINEPHRINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016964-005MARCAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016964-006MARCAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016964-007MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016964-008MARCAINE HYDROCHLORIDE W/ EPINEPHRINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016964-009MARCAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016964-010MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE0.75%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016964-012MARCAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016964-013MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
N016964-001AP
N016964-004AP
N016964-005AP
N016964-006AP
N016964-007AP
N016964-008AP
N016964-009AP
N016964-010AP
N016964-012AP
N016964-013AP

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 HYDROCHLORIDEHenry Schein, Inc.562f4499-f3b7-4d9e-b022-61172176c8832026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
MarcaineBUPIVACAINE HYDROCHLORIDEHenry Schein, Inc.2c6f9b85-e783-4ad4-a804-a0ff1a32ec2c2026-06-24Warnings, Adverse reactionsExact identifier
MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.67578b56-7540-487e-1fba-481255620e782026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
MARCAINE WITH EPINEPHRINEBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHenry Schein, Inc.d0d51133-882c-4f9e-ba1c-f037226305a12026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
MarcaineBUPIVACINE HYDROCHLORIDEHenry Schein, Inc.7d94e8e0-0d1e-4af3-973a-a480d7d517372026-01-26Warnings, Adverse reactionsExact identifier
Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHospira, Inc.93cf0914-de08-4ec6-8f8c-d663243b99582024-02-02Boxed warning, Warnings, Adverse reactionsExact identifier

Boxed warning cross-check#

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

boxed warning

Boxed Warning 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)]. WARNING: RISK OF CARDIAC ARREST WITH USE OF MARCAINE IN OBSTETRICAL ANESTHESIA See full prescribing information for complete boxed warning. 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 (5.1).

Warnings cross-check#

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

warnings and cautions

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 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. 5.2 Dose-Related Toxicity The safety and effectiveness of MARCAINE / MARCAINE WITH EPINEPHRINE depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient's state of consciousness should be performed after injection of MARCAINE / MARCAINE WITH EPINEPHRINE solutions. Possible early warning signs of central nervous system (CNS) toxicity are restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, CNS depression, or drowsiness. 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. 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. Use the lowest dosage of MARCAINE / MARCAINE WITH EPINEPHRINE that results in effective anesthesia to avoid high plasma levels and serious adverse effects. Avoid rapid injection of a large volume of MARCAINE / MARCAINE WITH EPINEPHRINE solution and administer fractional (incremental) doses when feasible. Injection of repeated doses of MARCAINE / MARCAINE WITH EPINEPHRINE may cause significant increases in plasma levels with each repeated dose due to slow accumulation of the drug or its metabolites, o...

Adverse reactions cross-check#

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

adverse reactions

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 Warnings and Precautions (5.1)] •Dose-Related Toxicity [see Warnings and Precautions (5.2)] •Methemoglobinemia [see Warnings and Precautions (5.3)] •Chondrolysis with Intra-Articular Infusion [see Warnings and Precautions (5.5)] •Severe, Persistent Hypertension, Cerebrovascular Accidents, and Bradycardia Due to Drug Interactions [see Warnings and Precautions (5.6)] •Cardiac Arrest with Intravenous Regional Anesthesia Use [see Contraindications (4), Warnings and Precautions (5.7)] •Allergic-Type Reactions [see Warnings and Precautions (5.8)] •Systemic Toxicities with Unintended Intravascular or Intrathecal Injection [see Warnings and Precautions (5.9)] •Respiratory Arrest Following Retrobulbar Block [see Warnings and Precautions (5.15)] The following adverse reactions from voluntary reports or clinical studies have been reported with bupivacaine or bupivacaine and epinephrine. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions to MARCAINE / MARCAINE WITH EPINEPHRINE 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, unintentional intravascular injection, or slow metabolic degradation. The most commonly encountered acute adverse reactions that demand immediate counter-measures were related to the CNS and the cardiovascular system. These adverse reactions were generally dose-related and due to high plasma levels which may have resulted from overdosage, rapid absorption from the injection site, diminished tolerance, or from unintentional intravascular injection of the local anesthetic solution. In addition to systemic dose-related toxicity, unintentional intrathecal injection of drug during the intended performance of caudal or lumbar epidural block or nerve blocks near the vertebral column (especially in the head and neck region) has resulted in underventilation or apnea ("Total or High Spinal"). Also, hypotension due to loss of sy...

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9906MarcaineBupivacaine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9906MarcaineBupivacaine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9907MarcaineBupivacaine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9907MarcaineBupivacaine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9907MarcaineBupivacaine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9908MARCAINE WITH EPINEPHRINEbupivacaine hydrochloride and epinephrine bitartrateHenry Schein, Inc.NDACurrent
0404-9908MARCAINE WITH EPINEPHRINEbupivacaine hydrochloride and epinephrine bitartrateHenry Schein, Inc.NDACurrent
0409-1541Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHospira, Inc.NDACurrent
0409-1541Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHospira, Inc.NDACurrent
0409-1559MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1559MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1559MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1559MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1559MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1559MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1559MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1559MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1560MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1560MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1560MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1560MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1560MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1560MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1560MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1560MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1582MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1582MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1582MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1582MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1582MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1582MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1582MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1582MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1587MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1587MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1587MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1587MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1587MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1587MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1587MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1587MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1610MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1610MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1610MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1610MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1610MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1610MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1610MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1610MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1746Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1746Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1746Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1746Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1746Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1746Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1746Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1746Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1749Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1749Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1749Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1749Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1749Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1749Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1749Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1749Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1752Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1752Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1752Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1752Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1752Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1752Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1752Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1752Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1755Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1755Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1755Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1755Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1755Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1755Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1755Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64445SUPPL2020-08-28
64375SUPPL2020-08-24
56320SUPPL2018-11-06
56259SUPPL2018-11-05
519SUPPL2012-02-01
10943SUPPL2012-01-30
10942SUPPL2010-02-25
518SUPPL2010-02-25
13062SUPPL2005-11-01
10941SUPPL2005-11-01