FDA.reportPublic FDA data

Marcaine

Product NDC
0409-1559
11-digit product format
004091559
Labeler code
0409
Product ID
0409-1559_ab9a44ba-9d09-4836-a829-ddb592007de0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Hospira, Inc.
Application
NDA016964
Marketing category
NDA
Marketing start
2005-08-23
Marketing end
0000-00-00
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
3 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0409-1559DDiscontinued by firm2026-07-31
excluded packagepackage0409-15590409-1559-10DDiscontinued by firm2026-07-31
excluded packagepackage0409-15590409-1559-30DDiscontinued by firm2026-07-31

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 HYDROCHLORIDEHospira, Inc.67578b56-7540-487e-1fba-481255620e782026-05-29Boxed 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 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 • Dose-Related Toxicity : Monitor cardiovascular and respiratory vital signs and patient's state of consciousness after injection of MARCAINE / MARCAINE WITH EPINEPHRINE. ( 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 MARCAINE 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 MARCAINE WITH EPINEPHRINE : MARCAINE WITH EPINEPHRINE 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 MARCAINE WITH EPINEPHRINE. ( 5.9 ) 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 prolonge...

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, hypotensio...

DailyMed Product Concepts#

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-1559-10Marcaine10 in 1 TRAYINJECTION, SOLUTION1037
0409-1559-18Marcaine10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1037
0409-1559-19Marcaine30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION3037
0409-1559-30Marcaine10 in 1 CARTONINJECTION, SOLUTION1037

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1559-10ML - Milliliter0409-1559a37558d4-3b94-40bc-be7b-5be60a7f573312012-07-24
0409-1559-18ML - Milliliter0409-1559e34766c1-5346-4bb2-9eee-c8a0262f548512015-09-10
0409-1559-19ML - Milliliter0409-15598df4f854-f39e-47be-86c0-6d9e49d4020b12015-09-10
0409-1559-30ML - Milliliter0409-1559eccdeefd-9950-4bc5-b0fc-7ce96e1b18f512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
EPINEPHRINE BITARTRATEACTIVE INGREDIENT30Q7KI53AKMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
BUPIVACAINEACTIVE MOIETYY8335394ROMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
EPINEPHRINEACTIVE MOIETYYKH834O4BHMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
MONOTHIOGLYCEROLINACTIVE INGREDIENTAAO1P0WSXJMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QTMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
WATERINACTIVE INGREDIENT059QF0KO0RMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
Bupivacaine HydrochlorideACTIVE INGREDIENT7TQO7W3VT8MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]1
Bupivacaine HydrochlorideACTIVE INGREDIENT7TQO7W3VT8DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Dexamethasone Sodium PhosphateACTIVE INGREDIENTAI9376Y64PDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Isopropyl AlcoholACTIVE INGREDIENTND2M416302DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41ADEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Povidone-IodineACTIVE INGREDIENT85H0HZU99MDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
BupivacaineACTIVE MOIETYY8335394RODEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
BupivacaineACTIVE MOIETYY8335394ROMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]1
DexamethasoneACTIVE MOIETY7S5I7G3JQLDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
IodineACTIVE MOIETY9679TC07X4DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Isopropyl AlcoholACTIVE MOIETYND2M416302DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
LidocaineACTIVE MOIETY98PI200987DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Nonoxynol-9INACTIVE INGREDIENT48Q180SH9TDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
WaterINACTIVE INGREDIENT059QF0KO0RDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1559MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]33Legacy NDC, 4 package rows20250529_67578b56-7540-487e-1fba-481255620e78.zip
0409-1559DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1Legacy NDC20150407_fd895819-b7d4-43bd-b804-f7b0722a00e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1867594BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1867596BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012377BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012396BUPivacaine HCl 0.25 % Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1672917BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1672919BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012384BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1724884BUPivacaine HCl 0.5 % in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1724787BUPivacaine HCl 0.75 % in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1724786BUPivacaine HCl 0.75 % in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1867612Marcaine 0.25 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1867614Marcaine 0.25 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012381Marcaine 0.25 % / EPINEPHrine 1:200,000 Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1725079Marcaine 0.25 % in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1725083Marcaine 0.25 % in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012400Marcaine 0.25 % Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1673242Marcaine 0.5 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1673243Marcaine 0.5 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012388Marcaine 0.5 % / EPINEPHrine 1:200,000 Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1725044Marcaine 0.5 % in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1725046Marcaine 0.5 % in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012406Marcaine 0.5 % Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1724796Marcaine 0.75 % in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1724794Marcaine 0.75 % in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
186761210 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection [Marcaine with Epinephrine]SBD67578b56-7540-487e-1fba-481255620e7838
172507910 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
167324210 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection [Marcaine with Epinephrine]SBD67578b56-7540-487e-1fba-481255620e7838
172504410 ML bupivacaine hydrochloride 5 MG/ML Injection [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
172479610 ML bupivacaine hydrochloride 7.5 MG/ML Injection [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
186761430 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection [Marcaine with Epinephrine]SBD67578b56-7540-487e-1fba-481255620e7838
172508330 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
167324330 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection [Marcaine with Epinephrine]SBD67578b56-7540-487e-1fba-481255620e7838
172504630 ML bupivacaine hydrochloride 5 MG/ML Injection [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
172479430 ML bupivacaine hydrochloride 7.5 MG/ML Injection [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
1012381bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution [Marcaine with Epinephrine]SBD67578b56-7540-487e-1fba-481255620e7838
1012400bupivacaine hydrochloride 2.5 MG/ML Injectable Solution [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
1012388bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution [Marcaine with Epinephrine]SBD67578b56-7540-487e-1fba-481255620e7838
1012406bupivacaine hydrochloride 5 MG/ML Injectable Solution [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
186759410 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
167291710 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
172478710 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
186759630 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
167291930 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
172488430 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
172478630 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
1012377bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injectable SolutionSCD67578b56-7540-487e-1fba-481255620e7838
1012396bupivacaine hydrochloride 2.5 MG/ML Injectable SolutionSCD67578b56-7540-487e-1fba-481255620e7838
1012384bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable SolutionSCD67578b56-7540-487e-1fba-481255620e7838
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCD67578b56-7540-487e-1fba-481255620e7838
172507910 ML Marcaine 2.5 MG/ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
172504410 ML Marcaine 5 MG/ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
172479610 ML Marcaine 7.5 MG/ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
172508330 ML Marcaine 2.5 MG/ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
172504630 ML Marcaine 5 MG/ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
172479430 ML Marcaine 7.5 MG/ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1867594bupivacaine HCl 0.25 % / epinephrine (as bitartrate) 1:200,000 per 10 mL InjectionSY67578b56-7540-487e-1fba-481255620e7838
1867596bupivacaine HCl 0.25 % / epinephrine 1:200,000 per 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1672917bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 10 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1672919bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1724884bupivacaine HCl 0.5 % in 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1724787bupivacaine HCl 0.75 % in 10 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1724786bupivacaine HCl 0.75 % in 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1724786bupivacaine HCl 225 MG per 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1724787bupivacaine HCl 75 MG per 10 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1012377bupivacaine hydrochloride 0.25 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable SolutionSY67578b56-7540-487e-1fba-481255620e7838
1012396bupivacaine hydrochloride 0.25 % Injectable SolutionSY67578b56-7540-487e-1fba-481255620e7838
1012384bupivacaine hydrochloride 0.5 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable SolutionSY67578b56-7540-487e-1fba-481255620e7838
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSY67578b56-7540-487e-1fba-481255620e7838
1867614Marcaine 0.25 % / epinephrine (as epinephrine bitartrate) 1:200,000 per 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1012381Marcaine 0.25 % / epinephrine 1:200,000 Injectable SolutionSY67578b56-7540-487e-1fba-481255620e7838

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1559-100040915591010 VIAL, SINGLE-DOSE in 1 TRAY (0409-1559-10) > 10 mL in 1 VIAL, SINGLE-DOSE (0409-1559-18) 2005-08-230000-00-00NoNoCurrent
0409-1559-180040915591810 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
0409-1559-190040915591930 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical
0409-1559-300040915593010 VIAL, SINGLE-DOSE in 1 CARTON (0409-1559-30) > 30 mL in 1 VIAL, SINGLE-DOSE (0409-1559-19) 2005-09-080000-00-00NoNoCurrent