FDA.reportPublic FDA data

10 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Marcaine]

RxCUI
1725079
RxNorm name
10 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Marcaine]
Display name
MARCAINE (Injectable)
Full name
10 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Marcaine]
Term type
SBD
Status
Active
Strength
2.5 mg/ml
Dose form
Injection 10 ml
Route
Injectable
Updated
2026-10-27 17:49:28

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012016
Active start
012016
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
bupivacaine hydrochloride2.5 MG / 1 MLbupivacainebupivacaine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Injection1649574

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
bupivacaine1815

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STR10 ML Marcaine 2.5 MG/ML Injection1NAMES
RxNorm Name10 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Marcaine]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI17250791CODES
MMSL_CODEMTH_RXN_BD149341CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0404-9770-100404-9770Marcaine bupivacaine hydrochlorideHenry Schein, Inc.NDA016964
0409-2510-250409-2510Marcaine BUPIVACAINE HYDROCHLORIDEHospira, Inc.NDA016964

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA0169640404-9770Marcaine bupivacaine hydrochlorideNDAHenry Schein, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 8 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00404977010rxnav_ndcsyes
00409155910rxnav_ndcsyes
00409155918rxnav_ndcsyes
00409251001rxnav_ndcsyes
00409251025rxnav_ndcsyes
00404990610rxnav_historical
50090236900rxnav_historical
52584055910rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

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
ndc (package): 0404-9770-10
ndc (product): 0404-9770
ndc11 (package): 00404977010
rxcui: 1725079

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
67578b56-7540-487e-1fba-481255620e78Marcaine 0.25 % in 10 ML Injection [PSN] · 10 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Marcaine] [SBD] · 10 ML Marcaine 2.5 MG/ML Injection [SY] · Marcaine 0.25 % in 10 ML Injection [SY]438These highlights do not include all the information needed to use MARCAINE™ and MARCAINE™ WITH EPINEPHRINE safely and effectively. See full prescribing information for MARCAINE™ and MARCAINE™ WITH EPINEPHRINE. MARCAINE™ (bupivacaine hydrochloride) injection, for infiltration, perineural, caudal, epidural, or retrobulbar use MARCAINE™ WITH EPINEPHRINE (bupivacaine hydrochloride and epinephrine) injection, for infiltration, perineural, caudal, or epidural use Initial U.S. Approval: 197220260529
562f4499-f3b7-4d9e-b022-61172176c883Marcaine 0.25 % in 10 ML Injection [PSN] · 10 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Marcaine] [SBD] · 10 ML Marcaine 2.5 MG/ML Injection [SY] · Marcaine 0.25 % in 10 ML Injection [SY]41These highlights do not include all the information needed to use MARCAINE™ and MARCAINE™ WITH EPINEPHRINE safely and effectively. See full prescribing information for MARCAINE™ and MARCAINE™ WITH EPINEPHRINE.MARCAINE™ (bupivacaine hydrochloride) injection, for infiltration, perineural, caudal, epidural, or retrobulbar use MARCAINE™ WITH EPINEPHRINE (bupivacaine hydrochloride and epinephrine) injection, for infiltration, perineural, caudal, or epidural use Initial U.S. Approval: 197220251202
fd895819-b7d4-43bd-b804-f7b0722a00e9Marcaine 0.25 % in 10 ML Injection [PSN] · 10 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Marcaine] [SBD] · 10 ML Marcaine 2.5 MG/ML Injection [SY] · Marcaine 0.25 % in 10 ML Injection [SY]41Dexamethasone Sodium Phosphate Injection,USP20140805

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
67578b56-7540-487e-1fba-481255620e78These highlights do not include all the information needed to use MARCAINE™ and MARCAINE™ WITH EPINEPHRINE safely and effectively. See full prescribing information for MARCAINE™ and MARCAINE™ WITH EPINEPHRINE. MARCAINE™ (bupivacaine hydrochloride) injection, for infiltration, perineural, caudal, epidural, or retrobulbar use MARCAINE™ WITH EPINEPHRINE (bupivacaine hydrochloride and epinephrine) injection, for infiltration, perineural, caudal, or epidural use Initial U.S. Approval: 1972Hospira, Inc. | Pfizer Healthcare India Private Limited20261023
67578b56-7540-487e-1fba-481255620e78These highlights do not include all the information needed to use MARCAINE™ and MARCAINE™ WITH EPINEPHRINE safely and effectively. See full prescribing information for MARCAINE™ and MARCAINE™ WITH EPINEPHRINE. MARCAINE™ (bupivacaine hydrochloride) injection, for infiltration, perineural, caudal, epidural, or retrobulbar use MARCAINE™ WITH EPINEPHRINE (bupivacaine hydrochloride and epinephrine) injection, for infiltration, perineural, caudal, or epidural use Initial U.S. Approval: 1972Hospira, Inc. | Pfizer Healthcare India Private Limited20261014
562f4499-f3b7-4d9e-b022-61172176c883These highlights do not include all the information needed to use MARCAINE™ and MARCAINE™ WITH EPINEPHRINE safely and effectively. See full prescribing information for MARCAINE™ and MARCAINE™ WITH EPINEPHRINE.MARCAINE™ (bupivacaine hydrochloride) injection, for infiltration, perineural, caudal, epidural, or retrobulbar use MARCAINE™ WITH EPINEPHRINE (bupivacaine hydrochloride and epinephrine) injection, for infiltration, perineural, caudal, or epidural use Initial U.S. Approval: 1972Henry Schein, Inc.20260630
67578b56-7540-487e-1fba-481255620e78These highlights do not include all the information needed to use MARCAINE™ and MARCAINE™ WITH EPINEPHRINE safely and effectively. See full prescribing information for MARCAINE™ and MARCAINE™ WITH EPINEPHRINE. MARCAINE™ (bupivacaine hydrochloride) injection, for infiltration, perineural, caudal, epidural, or retrobulbar use MARCAINE™ WITH EPINEPHRINE (bupivacaine hydrochloride and epinephrine) injection, for infiltration, perineural, caudal, or epidural use Initial U.S. Approval: 1972Hospira, Inc. | Pfizer Healthcare India Private Limited20260529
67578b56-7540-487e-1fba-481255620e78These highlights do not include all the information needed to use MARCAINE™ and MARCAINE™ WITH EPINEPHRINE safely and effectively. See full prescribing information for MARCAINE™ and MARCAINE™ WITH EPINEPHRINE. MARCAINE™ (bupivacaine hydrochloride) injection, for infiltration, perineural, caudal, epidural, or retrobulbar use MARCAINE™ WITH EPINEPHRINE (bupivacaine hydrochloride and epinephrine) injection, for infiltration, perineural, caudal, or epidural use Initial U.S. Approval: 1972Hospira, Inc. | Pfizer Healthcare India Private Limited20260423
562f4499-f3b7-4d9e-b022-61172176c883These highlights do not include all the information needed to use MARCAINE™ and MARCAINE™ WITH EPINEPHRINE safely and effectively. See full prescribing information for MARCAINE™ and MARCAINE™ WITH EPINEPHRINE.MARCAINE™ (bupivacaine hydrochloride) injection, for infiltration, perineural, caudal, epidural, or retrobulbar use MARCAINE™ WITH EPINEPHRINE (bupivacaine hydrochloride and epinephrine) injection, for infiltration, perineural, caudal, or epidural use Initial U.S. Approval: 1972Henry Schein, Inc.20251202
67578b56-7540-487e-1fba-481255620e78These highlights do not include all the information needed to use MARCAINE™ and MARCAINE™ WITH EPINEPHRINE safely and effectively. See full prescribing information for MARCAINE™ and MARCAINE™ WITH EPINEPHRINE. MARCAINE™ (bupivacaine hydrochloride) injection, for infiltration, perineural, caudal, epidural, or retrobulbar use MARCAINE™ WITH EPINEPHRINE (bupivacaine hydrochloride and epinephrine) injection, for infiltration, perineural, caudal, or epidural use Initial U.S. Approval: 1972Hospira, Inc. | Pfizer Healthcare India Private Limited20251106
00fb869a-40e7-4c85-8380-c5e0cdee8018HiGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use MARCAINE™ and MARCAINE™ WITH EPINEPHRINE safely and effectively. See full prescribing information for MARCAINE™ and MARCAINE™ WITH EPINEPHRINE. MARCAINE™ (bupivacaine hydrochloride) injection, for infiltration, perineural, caudal, epidural, or retrobulbar use MARCAINE™ WITH EPINEPHRINE (bupivacaine hydrochloride and epinephrine) injection, for infiltration, perineural, caudal, or epidural use Initial U.S. Henry Schein, Inc.20250924
00fb869a-40e7-4c85-8380-c5e0cdee8018HiGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use MARCAINE™ and MARCAINE™ WITH EPINEPHRINE safely and effectively. See full prescribing information for MARCAINE™ and MARCAINE™ WITH EPINEPHRINE. MARCAINE™ (bupivacaine hydrochloride) injection, for infiltration, perineural, caudal, epidural, or retrobulbar use MARCAINE™ WITH EPINEPHRINE (bupivacaine hydrochloride and epinephrine) injection, for infiltration, perineural, caudal, or epidural use Initial U.S. Henry Schein, Inc.20250903
67578b56-7540-487e-1fba-481255620e78These highlights do not include all the information needed to use MARCAINE™ and MARCAINE™ WITH EPINEPHRINE safely and effectively. See full prescribing information for MARCAINE™ and MARCAINE™ WITH EPINEPHRINE. MARCAINE™ (bupivacaine hydrochloride) injection, for infiltration, perineural, caudal, epidural, or retrobulbar use MARCAINE™ WITH EPINEPHRINE (bupivacaine hydrochloride and epinephrine) injection, for infiltration, perineural, caudal, or epidural use Initial U.S. Approval: 1972Hospira, Inc. | Pfizer Healthcare India Private Limited20250828
67578b56-7540-487e-1fba-481255620e78These highlights do not include all the information needed to use MARCAINE™ and MARCAINE™ WITH EPINEPHRINE safely and effectively. See full prescribing information for MARCAINE™ and MARCAINE™ WITH EPINEPHRINE. MARCAINE™ (bupivacaine hydrochloride) injection, for infiltration, perineural, caudal, epidural, or retrobulbar use MARCAINE™ WITH EPINEPHRINE (bupivacaine hydrochloride and epinephrine) injection, for infiltration, perineural, caudal, or epidural use Initial U.S. Approval: 1972Hospira, Inc. | Pfizer Healthcare India Private Limited20250825
f3184f46-6b6a-49f8-8045-448cb58e676bHiGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use MARCAINE™ and MARCAINE™ WITH EPINEPHRINE safely and effectively. See full prescribing information for MARCAINE™ and MARCAINE™ WITH EPINEPHRINE. MARCAINE™ (bupivacaine hydrochloride) injection, for infiltration, perineural, caudal, epidural, or retrobulbar use MARCAINE™ WITH EPINEPHRINE (bupivacaine hydrochloride and epinephrine) injection, for infiltration, perineural, caudal, or epidural use Initial U.S. General Injectables & Vaccines, Inc20221227
736cc923-1dc2-43e2-b0b9-178d9b0ba6ddA-S Medication Solutions20171211
fd895819-b7d4-43bd-b804-f7b0722a00e9Dexamethasone Sodium Phosphate Injection,USPProficient Rx LP20140805
a37558d4-3b94-40bc-be7b-5be60a7f5733National Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCN01BBAmidesATC1-4bupivacaine
FDASPLD000577AmidesCHEMhas_chemical_structurebupivacaine
FDASPLN0000175682Amide Local AnestheticEPChas_epcbupivacaine
FDASPLN0000175976Local AnesthesiaPEhas_pebupivacaine
MEDRTD002045BupivacaineCHEMhas_ingredientbupivacaine
MEDRTD002045BupivacaineCHEMhas_ingredientbupivacaine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withbupivacaine
MEDRTD004342Drug HypersensitivityDISEASEci_withbupivacaine hydrochloride
MEDRTD010146PainDISEASEmay_preventbupivacaine
MEDRTD010146PainDISEASEmay_preventbupivacaine hydrochloride
MEDRTD010149Postoperative PainDISEASEmay_treatbupivacaine
MEDRTD010149Postoperative PainDISEASEmay_treatbupivacaine hydrochloride
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moabupivacaine
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moabupivacaine hydrochloride
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moabupivacaine
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moabupivacaine hydrochloride
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_pebupivacaine
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_pebupivacaine hydrochloride
MEDRTN0000175976Local AnesthesiaPEhas_pebupivacaine hydrochloride
MEDRTN0000175976Local AnesthesiaPEhas_pebupivacaine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH2.5 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY10 ML
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA016964
NAMESPrescribable SynonymMarcaine 0.25 % in 10 ML Injection
NAMESTallman Synonym10 ML BUPivacaine hydrochloride 2.5 MG/ML Injection [Marcaine]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon