FDA.reportPublic FDA data

Application 070597

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.5%NoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070597-001BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP1987-03-03

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A070597-001AP

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.02a845c3-4521-4926-e397-25ab536e7cf62026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHenry Schein, Inc496ccd9e-d1c3-4b5a-93b6-0c457faa15892025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst950d82b6-76a1-0c08-e053-2a95a90a3a922024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier

Boxed warning cross-check#

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boxed warning

WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA There have been reports of cardiac arrest with difficult resuscitation or death during use of Bupivacaine Hydrochloride Injection 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 Bupivacaine Hydrochloride Injection 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 BUPIVACAINE HYDROCHLORIDE INJECTION 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 Bupivacaine Hydrochloride Injection 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 Bupivacaine Hydrochloride Injection 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#

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warnings and cautions

5 WARNINGS AND PRECAUTIONS • Dose-Related Toxicity : Monitor cardiovascular and respiratory vital signs and patient's state of consciousness after injection of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection. ( 5.2 ) • Methemoglobinemia : Cases of methemoglobinemia have been reported in association with local anesthetic use. See full prescribing information for more detail on managing these risks. ( 5.3 ) • Chondrolysis with Intra-Articular Infusion : Intra-articular infusions of local anesthetics including Bupivacaine Hydrochloride Injection following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. ( 5.5 ) • Risk of Cardiac Arrest with Intravenous Regional Anesthesia Use (Bier Block) : There have been reports of cardiac arrest and death during the use of bupivacaine for intravenous regional anesthesia (Bier Block). ( 5.7 ) • Allergic-Type Reactions to Sulfites in Bupivacaine Hydrochloride and Epinephrine Injection : Bupivacaine Hydrochloride and Epinephrine Injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. ( 5.8 ) • Risk of Systemic Toxicities with Unintended Intravascular or Intrathecal Injection : Unintended intravascular or intrathecal injection may be associated with systemic toxicities, including CNS or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest. Aspirate for blood or cerebrospinal fluid (where applicable) prior to each dose and consider using a test dose of Bupivacaine Hydrochloride and Epinephrine Injection. ( 5.9 ) 5.1 Risk of Cardiac Arrest with Use of Bupivacaine Hydrochloride Injection in Obstetrical Anesthesia There have been reports of cardiac arrest with difficult resuscitation or death during use of Bupivacaine Hydrochloride Injection 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 intravasc...

Adverse reactions cross-check#

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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 Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine 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, 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 ...

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9827Bupivacaine HydrochlorideBupivacaine HydrochlorideHenry Schein, IncANDACurrent
0404-9827Bupivacaine HydrochlorideBupivacaine HydrochlorideHenry Schein, IncANDACurrent
0409-1163Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1163Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1163Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1163Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1163Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1163Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1163Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
51662-1396BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1396BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1396BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1396BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1396BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1396BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-163Bupivacaine HydrochlorideBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-163Bupivacaine HydrochlorideBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-163Bupivacaine HydrochlorideBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-163Bupivacaine HydrochlorideBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent