FDA.reportPublic FDA data

30 ML bupivacaine hydrochloride 5 MG/ML Injection

RxCUI
1724884
RxNorm name
30 ML bupivacaine hydrochloride 5 MG/ML Injection
Display name
BUPivacaine (Injectable)
Full name
30 ML bupivacaine hydrochloride 5 MG/ML Injection
Term type
SCD
Status
Active
Strength
5 mg/ml
Dose form
Injection 30 ml
Route
Injectable
Updated
2026-10-27 17:49:18

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 hydrochloride5 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 BUPivacaine hydrochloride 5 MG/ML Injection1NAMES
RxNorm Name30 ML bupivacaine hydrochloride 5 MG/ML Injection1NAMES
RxNorm Synonymbupivacaine HCl 0.5 % in 30 ML Injection1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
8 linked values
8CODES
RxCUI17248841CODES
MMSL_CODEMTH_RXN_BD149351CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0143-9334-100143-9334Bupivacaine Hydrochloride Bupivacaine HydrochlorideHikma Pharmaceuticals USA Inc.ANDA204842
0409-1162-020409-1162Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDEHospira, Inc.ANDA070584
31722-276-3331722-276BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDECamber Pharmaceuticals, Inc.ANDA217821
31722-276-3431722-276BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDECamber Pharmaceuticals, Inc.ANDA217821
55150-170-3055150-170Bupivacaine Hydrochloride Bupivacaine HydrochlorideEugia US LLCANDA203895
70594-118-0170594-118Bupivacaine HCl Bupivacaine hydrochlorideXellia Pharmaceuticals USA LLCANDA091487
72603-602-2572603-602BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDENorthStar RxLLCANDA217821
83270-166-0183270-166Bupivacaine Hydrochloride Bupivacaine HydrochlorideONESOURCE SPECIALTY PHARMA LIMITEDANDA091487
84549-162-0284549-162Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDEProPharma DistributionANDA070584

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA2048420143-9334Bupivacaine Hydrochloride Bupivacaine HydrochlorideANDAHikma Pharmaceuticals USA Inc.
ANDA0705840409-1162Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDEANDAHospira, Inc.
ANDA21782131722-276BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDEANDACamber Pharmaceuticals, Inc.
ANDA20389555150-170Bupivacaine Hydrochloride Bupivacaine HydrochlorideANDAEugia US LLC
ANDA09148770594-118Bupivacaine HCl Bupivacaine hydrochlorideANDAXellia Pharmaceuticals USA LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 27 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00143933401rxnav_ndcsyes
00143933410rxnav_ndcsyes
00409116202rxnav_ndcsyes
00409116209rxnav_ndcsyes
00409116210rxnav_ndcsyes
00409116219rxnav_ndcsyes
31722027630rxnav_ndcsyes
31722027633rxnav_ndcsyes
31722027634rxnav_ndcsyes
55150017030rxnav_ndcsyes
70594011801rxnav_ndcsyes
71288072532rxnav_ndcsyes
72603060201rxnav_ndcsyes
72603060225rxnav_ndcsyes
83270016601rxnav_ndcsyes
84549016202rxnav_ndcsyes
00409116101rxnav_historical
00409116118rxnav_historical
25021066430rxnav_historical
55154695905rxnav_historical
55154695908rxnav_historical
61786074002rxnav_historical
70518049900rxnav_historical
70518049901rxnav_historical
70518049902rxnav_historical
70529000501rxnav_historical
82449022601rxnav_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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDENorthStar RxLLCee3b5bbe-4013-4682-b6ee-db86e77880772026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 72603-602-25
ndc (product): 72603-602
ndc11 (package): 72603060225
ndc11 (package): 72603060201
rxcui: 1724884
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDECamber Pharmaceuticals, Inc.0e552e3a-cf52-4d74-9381-6cc1b29b4c902026-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 31722-276-33
ndc (package): 31722-276-34
ndc (product): 31722-276
ndc11 (package): 31722027633
ndc11 (package): 31722027634
ndc11 (package): 31722027630
rxcui: 1724884
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.02a845c3-4521-4926-e397-25ab536e7cf62026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 0409-1162-02
ndc (product): 0409-1162
ndc11 (package): 00409116219
ndc11 (package): 00409116202
rxcui: 1724884
MarcaineBUPIVACINE HYDROCHLORIDEHenry Schein, Inc.7d94e8e0-0d1e-4af3-973a-a480d7d517372026-01-26Warnings, Adverse reactionsExact identifier
rxcui: 1724884
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEProPharma Distribution42c973e2-307b-924c-e063-6394a90a737a2025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 84549-162-02
ndc (product): 84549-162
ndc11 (package): 84549016202
rxcui: 1724884
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEONESOURCE SPECIALTY PHARMA LIMITED5c10e3a1-7806-40c7-afd2-4c420e1418232025-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 83270-166-01
ndc (product): 83270-166
ndc11 (package): 83270016601
rxcui: 1724884
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEEugia US LLCffecf450-1f01-4721-8e10-2513858526122025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 55150-170-30
ndc (product): 55150-170
ndc11 (package): 55150017030
rxcui: 1724884
SENSORCAINE MPFBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCb6bfc04a-1868-4630-9ca1-8c027af97ce32024-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1724884
SENSORCAINE MPFBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCeb6d8fee-def4-4c96-9972-695e8cea8ea82024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1724884
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.8815c8c6-eed8-4afe-a5c1-44d2194025a32024-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 0143-9334-10
ndc (product): 0143-9334
ndc11 (package): 00143933410
ndc11 (package): 00143933401
rxcui: 1724884
Bupivacaine HClBUPIVACAINE HYDROCHLORIDEXellia Pharmaceuticals USA LLCf29c905e-9a55-446f-a89d-860ad9ade7ad2023-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 70594-118-01
ndc (product): 70594-118
ndc11 (package): 70594011801
rxcui: 1724884
SENSORCAINE MPFBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCdcf3c0ad-9eb8-4ee7-96df-d0db7ff231752022-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1724884

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 · 15 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
02a845c3-4521-4926-e397-25ab536e7cf6BUPivacaine HCl 0.5 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 5 MG/ML Injection [SCD] · bupivacaine HCl 0.5 % in 30 ML Injection [SY]339These 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 ep20260309
67578b56-7540-487e-1fba-481255620e78BUPivacaine HCl 0.5 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 5 MG/ML Injection [SCD] · bupivacaine HCl 0.5 % in 30 ML Injection [SY]338These 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
eb6d8fee-def4-4c96-9972-695e8cea8ea8BUPivacaine HCl 0.5 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 5 MG/ML Injection [SCD] · bupivacaine HCl 0.5 % in 30 ML Injection [SY]310Sensorcaine ® (bupivacaine HCl Injection, USP) Sensorcaine ® -MPF (bupivacaine HCl Injection, USP) Sensorcaine ® with Epinephrine (bupivacaine HCl and epinephrine Injection, USP) 1:200,000 (as bitartrate) Sensorcaine ® -MPF with Epinephrine (bupivacaine HCl and epinephrine Injection, USP) 1:200,000 (as bitartrate)20241015
ffecf450-1f01-4721-8e10-251385852612BUPivacaine HCl 0.5 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 5 MG/ML Injection [SCD] · bupivacaine HCl 0.5 % in 30 ML Injection [SY]39These 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: 197220250529
8815c8c6-eed8-4afe-a5c1-44d2194025a3BUPivacaine HCl 0.5 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 5 MG/ML Injection [SCD] · bupivacaine HCl 0.5 % in 30 ML Injection [SY]34These 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: 197220240411
0e552e3a-cf52-4d74-9381-6cc1b29b4c90BUPivacaine HCl 0.5 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 5 MG/ML Injection [SCD] · bupivacaine HCl 0.5 % in 30 ML Injection [SY]33These 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: 197220260404
ed820739-b9f4-454b-b8b7-a9df81f24c4eBUPivacaine HCl 0.5 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 5 MG/ML Injection [SCD] · bupivacaine HCl 0.5 % in 30 ML Injection [SY]33Durapren 0.5% Injection System20220222
daec9ee4-b666-485e-a153-4b5e5acc48a1BUPivacaine HCl 0.5 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 5 MG/ML Injection [SCD] · bupivacaine HCl 0.5 % in 30 ML Injection [SY]32These 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: 197220260417
42c973e2-307b-924c-e063-6394a90a737aBUPivacaine HCl 0.5 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 5 MG/ML Injection [SCD] · bupivacaine HCl 0.5 % in 30 ML Injection [SY]32These 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 ep20251218
ee3b5bbe-4013-4682-b6ee-db86e7788077BUPivacaine HCl 0.5 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 5 MG/ML Injection [SCD] · bupivacaine HCl 0.5 % in 30 ML Injection [SY]32These 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: 197220251017
f29c905e-9a55-446f-a89d-860ad9ade7adBUPivacaine HCl 0.5 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 5 MG/ML Injection [SCD] · bupivacaine HCl 0.5 % in 30 ML Injection [SY]32These 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: 197220230609
7d94e8e0-0d1e-4af3-973a-a480d7d51737BUPivacaine HCl 0.5 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 5 MG/ML Injection [SCD] · bupivacaine HCl 0.5 % in 30 ML Injection [SY]31These 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: 197220260126
5c10e3a1-7806-40c7-afd2-4c420e141823BUPivacaine HCl 0.5 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 5 MG/ML Injection [SCD] · bupivacaine HCl 0.5 % in 30 ML Injection [SY]31These 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 use. Initial U.S. Approval: 197220251128
b6bfc04a-1868-4630-9ca1-8c027af97ce3BUPivacaine HCl 0.5 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 5 MG/ML Injection [SCD] · bupivacaine HCl 0.5 % in 30 ML Injection [SY]31Sensorcaine ® -MPF (bupivacaine HCl Injection, USP) Sensorcaine ® -MPF with Epinephrine (bupivacaine HCl and epinephrine Injection, USP) 1:200,000 (as bitartrate)20241118
dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175BUPivacaine HCl 0.5 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 5 MG/ML Injection [SCD] · bupivacaine HCl 0.5 % in 30 ML Injection [SY]31Sensorcaine ® -MPF (bupivacaine HCl Injection, USP) Sensorcaine ® -MPF with Epinephrine (bupivacaine HCl and epinephrine Injection, USP) 1:200,000 (as bitartrate)20220817

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
ee3b5bbe-4013-4682-b6ee-db86e7788077These 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: 1972NorthStar RxLLC | Aspiro Pharma Limited20260720
daec9ee4-b666-485e-a153-4b5e5acc48a1These 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: 1972Meitheal Pharmaceuticals Inc | Kindos Pharmaceuticals Co., Ltd.20260417
0e552e3a-cf52-4d74-9381-6cc1b29b4c90These 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: 1972Camber Pharmaceuticals, Inc. | Aspiro Pharma Limited20260404
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
42c973e2-307b-924c-e063-6394a90a737aThese 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 epProPharma Distribution20251218
5c10e3a1-7806-40c7-afd2-4c420e141823These 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 use. Initial U.S. Approval: 1972ONESOURCE SPECIALTY PHARMA LIMITED | Onesource Specialty Pte. Limited | ONESOURCE SPECIALTY PHARMA LIMITED - Sterile Product Division20251128
42c973e2-307b-924c-e063-6394a90a737aThese 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 epProPharma Distribution20251104
ee3b5bbe-4013-4682-b6ee-db86e7788077These 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: 1972NorthStar RxLLC | Aspiro Pharma Limited20251017
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
ee3b5bbe-4013-4682-b6ee-db86e7788077These 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: 1972NorthStar RxLLC | Aspiro Pharma Limited20241004
8815c8c6-eed8-4afe-a5c1-44d2194025a3These 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: 1972Hikma Pharmaceuticals USA Inc.20240411
f29c905e-9a55-446f-a89d-860ad9ade7adThese 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: 1972Xellia Pharmaceuticals USA LLC20230609
dfa56ae0-72a5-4294-bd29-25bdb9549f9bHIGHLIGHTS OF PRESCRIBING INFORMATION These 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: 1972Steriscience Specialties Private Limited | Steriscience Pte. Limited20230605
ed820739-b9f4-454b-b8b7-a9df81f24c4eDurapren 0.5% Injection SystemIT3 Medical LLC20220222
8c33a692-de53-43c2-81ae-a54f87598416National Council for Prescription Drug Programs20120724
d78a5eb5-94ad-4eb4-ac17-79c964dc7364National 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_STRENGTH5 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY30 ML
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA070584
CODESANDAANDA091487
CODESANDAANDA203895
CODESANDAANDA204842
CODESANDAANDA217821
CODESVUID4041272
NAMESPrescribable SynonymBUPivacaine HCl 0.5 % in 30 ML Injection
NAMESTallman Synonym30 ML BUPivacaine hydrochloride 5 MG/ML Injection
NAMESTallman SynonymBUPivacaine HCl 0.5 % in 30 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