FDA.reportPublic FDA data

30 ML bupivacaine hydrochloride 7.5 MG/ML Injection [Marcaine]

RxCUI
1724794
RxNorm name
30 ML bupivacaine hydrochloride 7.5 MG/ML Injection [Marcaine]
Display name
MARCAINE (Injectable)
Full name
30 ML bupivacaine hydrochloride 7.5 MG/ML Injection [Marcaine]
Term type
SBD
Status
Active
Strength
7.5 mg/ml
Dose form
Injection 30 ml
Route
Injectable
Updated
2026-10-27 17:49:03

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 hydrochloride7.5 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_STR30 ML Marcaine 7.5 MG/ML Injection1NAMES
RxNorm Name30 ML bupivacaine hydrochloride 7.5 MG/ML Injection [Marcaine]1NAMES
RxNorm Synonym
3 linked values
3NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID67578b56-7540-487e-1fba-481255620e781CODES
RxCUI17247941CODES
MMSL_CODEMTH_RXN_BD149361CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0409-2253-250409-2253Marcaine BUPIVACAINE HYDROCHLORIDEHospira, Inc.NDA016964

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA0169640409-2253Marcaine BUPIVACAINE HYDROCHLORIDENDAHospira, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 21 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00409158219rxnav_ndcsyes
00409158229rxnav_ndcsyes
00409225301rxnav_ndcsyes
00409225325rxnav_ndcsyes
00024121402rxnav_historical_indirect
00024121410rxnav_historical_indirect
00024121430rxnav_historical_indirect
00024122910rxnav_historical_indirect
00074158210rxnav_historical_indirect
00074158229rxnav_historical_indirect
00074158230rxnav_historical_indirect
00074176102rxnav_historical_indirect
00074176162rxnav_historical_indirect
00074361352rxnav_historical_indirect
00409158210rxnav_historical_indirect
00409158218rxnav_historical_indirect
00409176102rxnav_historical_indirect
00409176118rxnav_historical_indirect
00409176119rxnav_historical_indirect
00409176162rxnav_historical_indirect
54569166000rxnav_historical_indirect

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
Marcaine SpinalBUPIVACAINE HYDROCHLORIDE IN DEXTROSEHospira, Inc.9679cc05-2f8a-4e88-53b5-6e9122c8b8c02026-06-23Warnings, Adverse reactionsExact identifier
ndc11 (package): 00409176119
ndc11 (package): 00409176162
ndc11 (package): 00409176118
ndc11 (package): 00409176102

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
67578b56-7540-487e-1fba-481255620e78Marcaine 0.75 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 7.5 MG/ML Injection [Marcaine] [SBD] · 30 ML Marcaine 7.5 MG/ML Injection [SY] · Marcaine 0.75 % in 30 ML Injection [SY] · Marcaine 225 MG per 30 ML Injection [SY]538These 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

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
9679cc05-2f8a-4e88-53b5-6e9122c8b8c0These highlights do not include all the information needed to use MARCAINE ® SPINAL safely and effectively. See full prescribing information for MARCAINE ® SPINAL. MARCAINE ® SPINAL (bupivacaine hydrochloride in dextrose injection) for subarachnoid injection Initial U.S. Approval: 1984Hospira, Inc. | Pfizer Healthcare India Private Limited20260623
9679cc05-2f8a-4e88-53b5-6e9122c8b8c0These highlights do not include all the information needed to use MARCAINE ® SPINAL safely and effectively. See full prescribing information for MARCAINE ® SPINAL. MARCAINE ® SPINAL (bupivacaine hydrochloride in dextrose injection) for subarachnoid injection Initial U.S. Approval: 1984Hospira, Inc. | Pfizer Healthcare India Private Limited20250513
b32ea505-8712-4b65-947e-b774252b93edSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20200316
f7f423ac-9328-428a-9358-a49100935803Smiths Medical ASD, Inc. | Hospira, Inc.20161103
8d27e3a8-292f-4afb-9277-03bce380364cSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20161017
e877d058-1bbe-4171-bd57-3fd3e849de5cSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20161013
a2f89908-ee69-4d79-9c95-9725985f16d5Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20161003
a0a773ce-d637-436f-8f17-a867b285f8edSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20160929
891e910b-17de-4ab8-a79b-e092e8641fa6Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20160928
8801fbd4-ff09-4aec-a41f-9ff5883c246fSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20160928
e95b8043-e5e9-478a-8993-f30b3c8edf5aSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20160906
af0d2b6a-6a44-4d8e-87b1-29a3ee1ff805Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20160831
f04a27be-c2a4-4058-81d2-528782be6d2dSmiths Medical ASD, Inc. | Hospira, Inc. | Kwang Myung Pharm. Co., Ltd. | Aplicare, Inc.20160620
7ed96d02-ca26-430b-bdb5-634d8b088226Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20160520
fdad4127-3458-498c-8674-439eab28a0fcSmiths Medical ASD, Inc. | Hospira, Inc.20160427
9a127754-0b0e-44ac-953a-0685a8b7b175Smiths Medical ASD, Inc. | Hospira, Inc.20151229
70e2c96a-9284-40b2-8271-79f3a8dada53Smiths Medical ASD, Inc. | Hospira, Inc.20150630
acd082d1-c167-4350-b3f2-6b8384d25140Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20150612
733b51c6-1128-4eaf-8ebb-722c7cc7eb0aSmiths Medical ASD, Inc. | Hospira, Inc. | 3M Company20150528
d03c6758-2e38-4777-bb3b-c0f5b077e4b8Smiths Medical ASD, Inc. | Hospira, Inc. | 3M Company20150219
d35a9f96-a0db-4060-9f9d-ba2117288fd0Smiths Medical ASD, Inc. | Hospira, Inc. | 3M Company20150218
bd8075e4-9dff-48a5-bd36-659d926c7735Smiths Medical ASD, Inc. | Hospira, Inc. | 3M Company20150218
fc5b6260-09c4-4522-bddf-b93d5a2d02e5Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc. | 3M Company20150211
bfd25295-4ae5-4f37-916d-752d269682e4Smiths Medical ASD, Inc. | Hospira, Inc.20141017
a7ba3956-f343-4a8c-8ad4-3dc20342e16dSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20140820
f7abd8c3-4a29-4416-b5e2-153d49b802d9Smiths Medical ASD, Inc. | Hospira, Inc. | Kwang Myung Pharm. Co., Ltd. | Aplicare, Inc.20130904
969d14d0-3df1-4cae-ac79-59b535cecfb4Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc. | Kwang Myung Pharm. Co., Ltd.20121116
f05b2042-3183-486f-bf69-409acf87e6abSmiths Medical ASD, Inc. | Hospira, Inc. | Kwang Myung Pharm. Co., Ltd. | Aplicare, Inc.20121115
cb41de08-0381-4f6f-bcd4-95feda248dacSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20121101
980692b6-5e76-4276-aae0-628f2759e479Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120904
984668f0-4061-412d-9f39-62b33ea4a77eSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120904
a036507c-a4c2-4774-b4f5-617fcaf12b87National Council for Prescription Drug Programs20120724
eea7b068-06d4-4a04-8a8a-20b3812561c8Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120625
e8240633-04c4-4789-9b64-f11b319c6a8aSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120622
f7dcea2d-0dd4-48e6-9c7f-762331088298Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120614
f0456563-acf1-4643-823a-2517e87adf49Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120612
f9609aa3-cba3-4478-bf77-22d594ecd728Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120404
74df795f-0a99-42f9-a604-e0fed5ae2b71Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120403
8a010871-9422-4bf7-87f7-5850b70a554aSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120402
7922bef8-466c-4e27-921b-4bc7032ed3edSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120308

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_STRENGTH7.5 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY30 ML
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA016964
NAMESPrescribable SynonymMarcaine 0.75 % in 30 ML Injection
NAMESTallman Synonym30 ML BUPivacaine hydrochloride 7.5 MG/ML Injection [Marcaine]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon