FDA.reportPublic FDA data

2 ML bupivacaine hydrochloride 7.5 MG/ML Injection

RxCUI
1724784
RxNorm name
2 ML bupivacaine hydrochloride 7.5 MG/ML Injection
Display name
BUPivacaine (Injectable)
Full name
2 ML bupivacaine hydrochloride 7.5 MG/ML Injection
Term type
SCD
Status
Active
Strength
7.5 mg/ml
Dose form
Injection 2 ml
Route
Injectable
Updated
2026-10-27 17:48:53

RxNorm Status History#

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

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_STR2 ML BUPivacaine hydrochloride 7.5 MG/ML Injection1NAMES
RxNorm Name2 ML bupivacaine hydrochloride 7.5 MG/ML Injection1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
5 linked values
5CODES
RxCUI17247841CODES
MMSL_CODEBD55931CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0264-9379-880264-9379Bupivacaine Hydrochloride with Dextrose Bupivacaine Hydrochloride with DextroseB. Braun Medical Inc.ANDA209087
0409-3613-010409-3613Bupivacaine BUPIVACAINE HYDROCHLORIDE IN DEXTROSEHospira, Inc.ANDA071810
71351-022-1071351-022Bupivacaine Hydrochloride Bupivacaine hydrochlorideBrookfield Pharmaceuticals, LLC.ANDA212822
71351-022-5071351-022Bupivacaine Hydrochloride Bupivacaine hydrochlorideBrookfield Pharmaceuticals, LLC.ANDA212822
73293-0002-273293-0002Bupivacaine Hydrochloride Bupivacaine hydrochlorideHuons Co., Ltd.ANDA212822

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA2090870264-9379Bupivacaine Hydrochloride with Dextrose Bupivacaine Hydrochloride with DextroseANDAB. Braun Medical Inc.
ANDA0718100409-3613Bupivacaine BUPIVACAINE HYDROCHLORIDE IN DEXTROSEANDAHospira, Inc.
ANDA21282271351-022Bupivacaine Hydrochloride Bupivacaine hydrochlorideANDABrookfield Pharmaceuticals, LLC.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 52 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00264937988rxnav_ndcsyes
00409361301rxnav_ndcsyes
00409361311rxnav_ndcsyes
36000009210rxnav_ndcsyes
71351002202rxnav_ndcsyes
71351002210rxnav_ndcsyes
71351002250rxnav_ndcsyes
73293000201rxnav_ndcsyes
73293000202rxnav_ndcsyes
00024121402rxnav_historical_indirect
00024121410rxnav_historical_indirect
00024121430rxnav_historical_indirect
00024122910rxnav_historical_indirect
00074116401rxnav_historical_indirect
00074116501rxnav_historical_indirect
00074116502rxnav_historical_indirect
00074158210rxnav_historical_indirect
00074158229rxnav_historical_indirect
00074158230rxnav_historical_indirect
00074176102rxnav_historical_indirect
00074176162rxnav_historical_indirect
00074361301rxnav_historical_indirect
00074361352rxnav_historical_indirect
00074427401rxnav_historical_indirect
00074562301rxnav_historical_indirect
00074562302rxnav_historical_indirect
00074574701rxnav_historical_indirect
00186102603rxnav_historical_indirect
00186102688rxnav_historical_indirect
00186103701rxnav_historical_indirect
00186103702rxnav_historical_indirect
00186103712rxnav_historical_indirect
00186103792rxnav_historical_indirect
00409116401rxnav_historical_indirect
00409116501rxnav_historical_indirect
00409116502rxnav_historical_indirect
00409158210rxnav_historical_indirect
00409158229rxnav_historical_indirect
00409176102rxnav_historical_indirect
00409176162rxnav_historical_indirect
00409361352rxnav_historical_indirect
00409427401rxnav_historical_indirect
00409562301rxnav_historical_indirect
00409562302rxnav_historical_indirect
00548824300rxnav_historical_indirect
25021066510rxnav_historical_indirect
25021066530rxnav_historical_indirect
36000009201rxnav_historical
36000009205rxnav_historical
36000009225rxnav_historical
55150017110rxnav_historical_indirect
55150017230rxnav_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 · 7 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): 00409176162
ndc11 (package): 00409176102
rxcui: 1724784
Bupivacaine SpinalBUPIVACAINE HYDROCHLORIDE IN DEXTROSEHospira, Inc.7a8d2539-4422-4312-0298-207ef1a2948e2026-04-07Warnings, Adverse reactionsExact identifier
ndc (package): 0409-3613-01
ndc (product): 0409-3613
ndc11 (package): 00409361301
ndc11 (package): 00409361311
rxcui: 1724784
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.02a845c3-4521-4926-e397-25ab536e7cf62026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
ndc11 (package): 00409116501
ndc11 (package): 00409116502
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEBrookfield Pharmaceuticals, LLC.e8b32972-6984-4f1c-e053-2995a90a32772026-01-13Warnings, Adverse reactionsExact identifier
ndc (package): 71351-022-10
ndc (package): 71351-022-50
ndc (product): 71351-022
ndc11 (package): 71351002202
ndc11 (package): 71351002210
ndc11 (package): 71351002250
rxcui: 1724784
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEEugia US LLCffecf450-1f01-4721-8e10-2513858526122025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
ndc11 (package): 55150017110
ndc11 (package): 55150017230
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHuons Co., Ltd.2dc693df-3218-4a90-b3f7-21e80966a8512024-11-20Warnings, Adverse reactionsExact identifier
ndc (package): 73293-0002-2
ndc (product): 73293-0002
ndc11 (package): 73293000201
ndc11 (package): 73293000202
rxcui: 1724784
Bupivacaine Hydrochloride with DextroseBUPIVACAINE HYDROCHLORIDE WITH DEXTROSEB. Braun Medical Inc.ff43d2b6-acb4-45c8-96b6-971d2a7a67672024-11-05Warnings, Adverse reactionsExact identifier
ndc (package): 0264-9379-88
ndc (product): 0264-9379
ndc11 (package): 00264937988
rxcui: 1724784

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 · 7 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
7a8d2539-4422-4312-0298-207ef1a2948eBUPivacaine HCl 0.75 % in 2 ML Injection [PSN] · 2 ML bupivacaine hydrochloride 7.5 MG/ML Injection [SCD] · bupivacaine HCl 0.75 % per 2 ML Injection [SY] · bupivacaine HCl 15 MG per 2 ML Injection [SY]429These highlights do not include all the information needed to use BUPIVACAINE SPINAL safely and effectively. See full prescribing information for BUPIVACAINE SPINAL . BUPIVACAINE SPINAL (bupivacaine hydrochloride in dextrose injection) for subarachnoid injection Initial U.S. Approval: 198420260407
9679cc05-2f8a-4e88-53b5-6e9122c8b8c0BUPivacaine HCl 0.75 % in 2 ML Injection [PSN] · 2 ML bupivacaine hydrochloride 7.5 MG/ML Injection [SCD] · bupivacaine HCl 0.75 % per 2 ML Injection [SY] · bupivacaine HCl 15 MG per 2 ML Injection [SY]426These 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: 198420250513
ff43d2b6-acb4-45c8-96b6-971d2a7a6767BUPivacaine HCl 0.75 % in 2 ML Injection [PSN] · 2 ML bupivacaine hydrochloride 7.5 MG/ML Injection [SCD] · bupivacaine HCl 0.75 % per 2 ML Injection [SY] · bupivacaine HCl 15 MG per 2 ML Injection [SY]411These highlights do not include all the information needed to use BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION, USP safely and effectively. See full prescribing information for BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION, USP. BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION, USP for subarachnoid injection Initial U.S. Approval: 198420241105
2dc693df-3218-4a90-b3f7-21e80966a851BUPivacaine HCl 0.75 % in 2 ML Injection [PSN] · 2 ML bupivacaine hydrochloride 7.5 MG/ML Injection [SCD] · bupivacaine HCl 0.75 % per 2 ML Injection [SY] · bupivacaine HCl 15 MG per 2 ML Injection [SY]410Bupivacaine Hydrochloride in Dextrose Injection, USP STERILE HYPERBARIC SOLUTION FOR SPINAL ANESTHESIA Rx only20241120
e8b32972-6984-4f1c-e053-2995a90a3277BUPivacaine HCl 0.75 % in 2 ML Injection [PSN] · 2 ML bupivacaine hydrochloride 7.5 MG/ML Injection [SCD] · bupivacaine HCl 0.75 % per 2 ML Injection [SY] · bupivacaine HCl 15 MG per 2 ML Injection [SY]46Bupivacaine Hydrochloride in Dextrose Injection, USP STERILE HYPERBARIC SOLUTION FOR SPINAL ANESTHESIA Rx only20260113
6e04f24a-a4ca-4e84-b3b3-7deba0b9cad0BUPivacaine HCl 0.75 % in 2 ML Injection [PSN] · 2 ML bupivacaine hydrochloride 7.5 MG/ML Injection [SCD] · bupivacaine HCl 0.75 % per 2 ML Injection [SY] · bupivacaine HCl 15 MG per 2 ML Injection [SY]4220200318
493569d1-291b-4d89-aa0f-17474d90aa09BUPivacaine HCl 0.75 % in 2 ML Injection [PSN] · 2 ML bupivacaine hydrochloride 7.5 MG/ML Injection [SCD] · bupivacaine HCl 0.75 % per 2 ML Injection [SY] · bupivacaine HCl 15 MG per 2 ML Injection [SY]41General Surgery Kit20120925

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
02a845c3-4521-4926-e397-25ab536e7cf6These highlights do not include all the information needed to use BUPIVACAINE HYDROCHLORIDE INJECTION and BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION safely and effectively. See full prescribing information for BUPIVACAINE HYDROCHLORIDE INJECTION and BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION. BUPIVACAINE HYDROCHLORIDE injection, for infiltration, perineural, caudal, epidural, or retrobulbar use BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE injection, for infiltration, perineural, caudal, or epHospira, Inc. | Pfizer Healthcare India Private Limited20260309
ffecf450-1f01-4721-8e10-251385852612These highlights do not include all the information needed to use BUPIVACAINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for BUPIVACAINE HYDROCHLORIDE INJECTION. BUPIVACAINE HYDROCHLORIDE injection, for infiltration, perineural, caudal, epidural, or retrobulbar use Initial U.S. Approval: 1972Eugia US LLC | EUGIA PHARMA SPECIALITIES LIMITED20250529
2dc693df-3218-4a90-b3f7-21e80966a851Bupivacaine Hydrochloride in Dextrose Injection, USP STERILE HYPERBARIC SOLUTION FOR SPINAL ANESTHESIA Rx onlyHuons Co., Ltd.20241120
27c42bab-2a96-4aca-8fec-e778e2ca8134Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20161018
265665e6-f527-4746-af8d-38ba25110b19Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20161011
0316eedf-e8c1-483a-8d5a-e1bc1282ead5Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20160929
00eb9611-3173-49d2-a81f-164b9244fb87Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20160928
1c48aa77-0021-4628-9def-7f9e4c7bbb7aSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20160802
1c636622-85e2-4455-a20f-ce0102e806a6Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20160427
21283ec3-f1d0-4a35-80d8-f6fc5d30014dSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20160427
11b2f885-b837-455c-8d77-0b38e14e35c3Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20150930
0d8e930c-9709-4540-bde4-8e7039ce3606Smiths Medical ASD, Inc. | Hospira, Inc. | Kwang Myung Pharm. Co., Ltd.20150528
0222f7ec-86ae-474d-ae9a-8ca1b98938a3Smiths Medical ASD, Inc. | Hospira, Inc. | 3M Company20150312
272f30af-1f4a-406b-a23a-0d955ed6a0bbSmiths Medical ASD, Inc. | Hospira, Inc. | Kwang Myung Pharm. Co., Ltd. | 3M Company20140827
27cb8ee8-5cbf-4c43-97f0-5c8c38fd2f64Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20140303
13cb130f-ef0b-4aa6-8fce-4b1f5de922b3Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20131119
09abf090-af04-4381-963d-c88b93c82a21Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20130913
04ed52f2-bd25-413c-9791-053440bd8a85Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20130314
09156429-0163-4819-bfb0-19b412e905cbSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20121203
005bfa1f-b9fd-4d63-a926-515d341667ddSmiths Medical ASD, Inc. | Hospira, Inc. | Kwang Myung Pharm. Co., Ltd. | Aplicare, Inc.20121128
1c700cc5-f3c0-4398-a5cc-12a651996b67Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20121127
2708b5c7-fc57-48af-ab23-ff432c8644ebSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20121023
16bdb142-7760-4603-93ec-ae57125cdce2Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20121001
167936cf-f527-442f-95a4-a76ad2f9f930Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120917
15af6924-29ca-4efc-84f1-7f584db5a86bSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120820
1b822e60-ce74-4117-91a3-6b536f2d3a00Smiths Medical ASD, Inc. | Hospira, Inc.20120807
2228d7fe-9788-4a25-b09d-6a7b49cf7b93National Council for Prescription Drug Programs20120724
1e956e6e-4d80-44d4-985b-227b94eea277Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120723
27049fe9-8144-486e-b54a-66ec5bdef34eSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120717
177552ba-bd25-4111-9c2a-d424c9a9e63eSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120626
10161af7-527c-426e-ac8e-c43e4736f2c1Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120625
250644e0-94b7-4da2-821a-50f66b54eb35Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120621
1643ed50-7c75-4df9-bffb-f0353c97e3c2Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120620
213ec9ed-b3b2-4c00-b837-9d4f2a185079Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120618
2f88600e-4b76-43dd-8ded-a454b6ed8a0eSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120612
251e7648-292b-466e-aea0-da484dd7f781Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120521
27a82cef-a75a-4f41-97a1-023f7ba04fc0Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.20120409
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0d595be4-2a8d-46dd-b230-e5942e3a34b2Smiths Medical ASD, Inc. | Hospira, Inc.20120301
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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
ATTRIBUTESQUANTITY2 ML
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA071810
CODESANDAANDA209087
CODESANDAANDA212822
CODESVUID4004273
CODESVUID4004279
CODESVUID4044090
NAMESPrescribable SynonymBUPivacaine HCl 0.75 % in 2 ML Injection
NAMESTallman Synonym2 ML BUPivacaine hydrochloride 7.5 MG/ML Injection
NAMESTallman SynonymBUPivacaine HCl 0.75 % per 2 ML Injection
NAMESTallman SynonymBUPivacaine HCl 15 MG per 2 ML Injection
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File