FDA.reportPublic FDA data

Bupivacaine Hydrochloride

Product NDC
0409-1163
11-digit product format
004091163
Labeler code
0409
Product ID
0409-1163_6e442bfd-d3da-4913-8585-ce3485644364
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
PERINEURAL
Labeler
Hospira, Inc.
Application
ANDA070597
Marketing category
ANDA
Marketing start
2005-03-31
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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#

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
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.02a845c3-4521-4926-e397-25ab536e7cf62026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier

Boxed warning cross-check#

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

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#

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

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#

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 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 ...

Additional Listing Data#

Finished product
Yes
Brand name base
Bupivacaine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7TQO7W3VT8, 30Q7KI53AK
Rxcui1012377, 1012384, 1012396, 1012404, 1672917, 1672919, 1724786, 1724787, 1724880, 1724884, 1725078, 1725082, 1867594, 1867596

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-1163-01Bupivacaine Hydrochloride25 in 1 TRAYINJECTION, SOLUTION2539
0409-1163-18Bupivacaine Hydrochloride50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION5039

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1163-01ML - Milliliter0409-11632a069acd-3101-40a8-9726-c015a1de728812012-07-24
0409-1163-18ML - Milliliter0409-1163678a596a-2326-45e5-92e0-3a1dbebb3ec712017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
EPINEPHRINE BITARTRATEACTIVE INGREDIENT30Q7KI53AKBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
BUPIVACAINEACTIVE MOIETYY8335394ROBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
EPINEPHRINEACTIVE MOIETYYKH834O4BHBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D034955BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
WATERINACTIVE INGREDIENT059QF0KO0RBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
Bupivacaine HydrochlorideACTIVE INGREDIENT7TQO7W3VT8BUPIVACAINE HYDROCHLORIDE INJECTION [GENERAL INJECTABLES & VACCINES, INC]3
BupivacaineACTIVE MOIETYY8335394ROBUPIVACAINE HYDROCHLORIDE INJECTION [GENERAL INJECTABLES & VACCINES, INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1163BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]38Current NDC, Legacy NDC, 2 package rows20241017_02a845c3-4521-4926-e397-25ab536e7cf6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1867594BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1867596BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1012377BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 Injectable SolutionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1012396BUPivacaine HCl 0.25 % Injectable SolutionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1672917BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1672919BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1012384BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable SolutionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1724884BUPivacaine HCl 0.5 % in 30 ML InjectionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1724787BUPivacaine HCl 0.75 % in 10 ML InjectionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1724786BUPivacaine HCl 0.75 % in 30 ML InjectionPSN02a845c3-4521-4926-e397-25ab536e7cf639
186759410 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD02a845c3-4521-4926-e397-25ab536e7cf639
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD02a845c3-4521-4926-e397-25ab536e7cf639
167291710 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD02a845c3-4521-4926-e397-25ab536e7cf639
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD02a845c3-4521-4926-e397-25ab536e7cf639
172478710 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCD02a845c3-4521-4926-e397-25ab536e7cf639
186759630 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD02a845c3-4521-4926-e397-25ab536e7cf639
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD02a845c3-4521-4926-e397-25ab536e7cf639
167291930 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD02a845c3-4521-4926-e397-25ab536e7cf639
172488430 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD02a845c3-4521-4926-e397-25ab536e7cf639
172478630 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCD02a845c3-4521-4926-e397-25ab536e7cf639
1012377bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injectable SolutionSCD02a845c3-4521-4926-e397-25ab536e7cf639
1012396bupivacaine hydrochloride 2.5 MG/ML Injectable SolutionSCD02a845c3-4521-4926-e397-25ab536e7cf639
1012384bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable SolutionSCD02a845c3-4521-4926-e397-25ab536e7cf639
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCD02a845c3-4521-4926-e397-25ab536e7cf639
1867594bupivacaine HCl 0.25 % / epinephrine (as bitartrate) 1:200,000 per 10 mL InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1867596bupivacaine HCl 0.25 % / epinephrine 1:200,000 per 30 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1672917bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 10 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1672919bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 30 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1724884bupivacaine HCl 0.5 % in 30 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1724787bupivacaine HCl 0.75 % in 10 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1724786bupivacaine HCl 0.75 % in 30 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1724786bupivacaine HCl 225 MG per 30 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1724787bupivacaine HCl 75 MG per 10 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1012377bupivacaine hydrochloride 0.25 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable SolutionSY02a845c3-4521-4926-e397-25ab536e7cf639
1012396bupivacaine hydrochloride 0.25 % Injectable SolutionSY02a845c3-4521-4926-e397-25ab536e7cf639
1012384bupivacaine hydrochloride 0.5 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable SolutionSY02a845c3-4521-4926-e397-25ab536e7cf639
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSY02a845c3-4521-4926-e397-25ab536e7cf639
1012396BUPivacaine HCl 0.25 % Injectable SolutionPSN950d82b6-76a1-0c08-e053-2a95a90a3a9211
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSN950d82b6-76a1-0c08-e053-2a95a90a3a9211
1012396bupivacaine hydrochloride 2.5 MG/ML Injectable SolutionSCD950d82b6-76a1-0c08-e053-2a95a90a3a9211
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCD950d82b6-76a1-0c08-e053-2a95a90a3a9211
1012396bupivacaine hydrochloride 0.25 % Injectable SolutionSY950d82b6-76a1-0c08-e053-2a95a90a3a9211
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSY950d82b6-76a1-0c08-e053-2a95a90a3a9211
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSN496ccd9e-d1c3-4b5a-93b6-0c457faa15896
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCD496ccd9e-d1c3-4b5a-93b6-0c457faa15896
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSY496ccd9e-d1c3-4b5a-93b6-0c457faa15896

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1163-010040911630125 VIAL, MULTI-DOSE in 1 TRAY (0409-1163-01) / 50 mL in 1 VIAL, MULTI-DOSE (0409-1163-18) 2005-03-310000-00-00NoNoCurrent
0409-1163-180040911631850 mL in 1 VIAL, MULTI-DOSE50 mlHistorical