FDA.reportPublic FDA data

bupivacaine hydrochloride 5 MG/ML Injectable Solution [Marcaine]

RxCUI
1012406
RxNorm name
bupivacaine hydrochloride 5 MG/ML Injectable Solution [Marcaine]
Display name
MARCAINE (Injectable)
Full name
bupivacaine hydrochloride 5 MG/ML Injectable Solution [Marcaine]
Term type
SBD
Status
Active
Strength
5 mg/ml
Dose form
Sol
Route
Injectable
Updated
2026-10-27 17:46:41

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
102010
Active start
102010
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
bupivacaine hydrochloride5 MG / 1 MLbupivacainebupivacaine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Injectable Solution316949

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
bupivacaine1815

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRMarcaine 0.5 % Injectable Solution1NAMES
RxNorm Namebupivacaine hydrochloride 5 MG/ML Injectable Solution [Marcaine]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI10124061CODES
MMSL_CODEBD10501CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0409-0525-250409-0525Marcaine BUPIVACAINE HYDROCHLORIDEHospira, Inc.NDA016964

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA0169640409-0525Marcaine BUPIVACAINE HYDROCHLORIDENDAHospira, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 32 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00409052501rxnav_ndcsyes
00409052525rxnav_ndcsyes
00409161050rxnav_ndcsyes
00024121302rxnav_historical
00024121310rxnav_historical
00024121330rxnav_historical
00024121801rxnav_historical
00074156010rxnav_historical
00074156029rxnav_historical
00074156030rxnav_historical
00074161050rxnav_historical
00247030450rxnav_historical
00409156010rxnav_historical
00409156018rxnav_historical
00409156019rxnav_historical
00409156029rxnav_historical
49349075901rxnav_historical
49349075920rxnav_historical
50090187400rxnav_historical
52125024901rxnav_historical
52125024916rxnav_historical
52584056010rxnav_historical
52584056029rxnav_historical
54569141400rxnav_historical
54569166000rxnav_historical
54569229800rxnav_historical
54868313400rxnav_historical
54868313401rxnav_historical
54868343900rxnav_historical_indirect
55045325105rxnav_historical
58016934301rxnav_historical
61786021102rxnav_historical

UNII Substances#

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

No records found.

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 · 6 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
67578b56-7540-487e-1fba-481255620e78Marcaine 0.5 % Injectable Solution [PSN] · bupivacaine hydrochloride 5 MG/ML Injectable Solution [Marcaine] [SBD] · Marcaine 0.5 % Injectable Solution [SY] · Marcaine 5 MG/ML Injectable Solution [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
56b90729-de15-4df9-9590-4da216fa9cd9Marcaine 0.5 % Injectable Solution [PSN] · bupivacaine hydrochloride 5 MG/ML Injectable Solution [Marcaine] [SBD] · Marcaine 0.5 % Injectable Solution [SY] · Marcaine 5 MG/ML Injectable Solution [SY]44P-Care K80MX20200203
a7bceca8-7dda-4fff-80de-01858b90c928Marcaine 0.5 % Injectable Solution [PSN] · bupivacaine hydrochloride 5 MG/ML Injectable Solution [Marcaine] [SBD] · Marcaine 0.5 % Injectable Solution [SY] · Marcaine 5 MG/ML Injectable Solution [SY]44P-Care K40MX20200203
6a60cb55-530a-41ee-bc78-971eaf9f0850Marcaine 0.5 % Injectable Solution [PSN] · bupivacaine hydrochloride 5 MG/ML Injectable Solution [Marcaine] [SBD] · Marcaine 0.5 % Injectable Solution [SY] · Marcaine 5 MG/ML Injectable Solution [SY]4420120307
0029ecd1-a700-46a5-a5f9-c416fb2bb4f0Marcaine 0.5 % Injectable Solution [PSN] · bupivacaine hydrochloride 5 MG/ML Injectable Solution [Marcaine] [SBD] · Marcaine 0.5 % Injectable Solution [SY] · Marcaine 5 MG/ML Injectable Solution [SY]43Fossaoprin SPG4 Injection System20220222
5c32df04-cf50-45d5-9260-308ba585c407Marcaine 0.5 % Injectable Solution [PSN] · bupivacaine hydrochloride 5 MG/ML Injectable Solution [Marcaine] [SBD] · Marcaine 0.5 % Injectable Solution [SY] · Marcaine 5 MG/ML Injectable Solution [SY]43Fossaoprin SPG2 Injection System20220222

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
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
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
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
e244561f-357d-4a9f-a26d-716dbf37814bHiGHLIGHTS OF PRESCRIBING INFORMATION These 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, Inc20230413
28115cb6-118b-612a-e054-00144ff88e88ReadySharp-ATerrain Pharmaceuticals20171219
433c1e4f-b7b7-4eda-e054-00144ff88e88ReadySharp Anesthetics + DexamethasoneTerrain Pharmaceuticals20171219
43402281-92b1-61aa-e054-00144ff88e88ReadySharp Anesthetics + KetorolacTerrain Pharmaceuticals20171219
736cc923-1dc2-43e2-b0b9-178d9b0ba6ddA-S Medication Solutions20171211
2823a219-0466-5dda-e054-00144ff88e88ReadySharp-P80Terrain Pharmaceuticals20161213
28247e4a-0a18-0365-e054-00144ff88e88ReadySharp-P40Terrain Pharmaceuticals20161213
43775cf1-4477-449a-e054-00144ff88e88ReadySharp Anesthetics + Methylprednisolone 80Terrain Pharmaceuticals20161209
432c2026-99ec-49e0-e054-00144ff8d46cReadySharp Anesthetics + BetamethasoneTerrain Pharmaceuticals20161208
f23a3dc4-62e9-46d0-a4b7-383dd5e02911Proficient Rx LP20130530
50473199-dfdf-43cc-a172-0796d1af30fcNational Council for Prescription Drug Programs20120724
2d596c5c-df94-459f-ab85-48633ec02643National Council for Prescription Drug Programs20120724
7976a937-5080-42c8-a0ba-a5fd0ed552edNational Council for Prescription Drug Programs20120724
9e377377-5a6a-40d4-99d0-12eb4969d433National Council for Prescription Drug Programs20120724
f93fc79b-36ff-402d-84b1-da9c820e076bNational Council for Prescription Drug Programs20120724
6a60cb55-530a-41ee-bc78-971eaf9f0850Physicians Total Care, Inc.20120307
8db7c501-993a-444d-a819-d1f9df1d7b62Marcaine (bupivacaine HCL) 0.5% Injection, USP 30 mL Single Dose VialGeneral Injectables & Vaccines, Inc20110425

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_STRENGTH5 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA014901
CODESNDANDA016964
NAMESPrescribable SynonymMarcaine 0.5 % Injectable Solution
NAMESTallman SynonymBUPivacaine hydrochloride 5 MG/ML Injectable Solution [Marcaine]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon