FDA.reportPublic FDA data

SENSORCAINE

Product NDC
63323-467
11-digit product format
633230467
Labeler code
63323
Product ID
63323-467_2b1a1f80-cb29-4ac1-9e72-20225ed45715
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
PERINEURAL
Labeler
Fresenius Kabi USA, LLC
Application
NDA018304
Marketing category
NDA
Marketing start
2010-11-19
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SENSORCAINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7TQO7W3VT8, 30Q7KI53AK
Rxcui1012391, 1012396, 1012404, 1012421, 1012455, 1012457, 1672917, 1672919, 1673296, 1673298, 1724880, 1724881, 1724884, 1724885, 1725078, 1725082, 1725175, 1725177

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
a831e694-3663-4a83-82be-6c309429f750Product name220200608
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-467-01SENSORCAINE50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION5010
63323-467-57SENSORCAINE25 in 1 TRAYINJECTION, SOLUTION2510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-467-01ML - Milliliter63323-467088c5bdc-07a9-4f30-8e6b-1bfdfaa2550d12021-12-08
63323-467-57ML - Milliliter63323-46741dfd54e-4aab-423b-ad8b-f50dcb12791d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
EPINEPHRINE BITARTRATEACTIVE INGREDIENT30Q7KI53AKSENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
BUPIVACAINEACTIVE MOIETYY8335394ROSENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
EPINEPHRINEACTIVE MOIETYYKH834O4BHSENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBSENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CSENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-467SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]10Current NDC, Legacy NDC, 2 package rows20241031_eb6d8fee-def4-4c96-9972-695e8cea8ea8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSNeb6d8fee-def4-4c96-9972-695e8cea8ea810
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSNeb6d8fee-def4-4c96-9972-695e8cea8ea810
1012396BUPivacaine HCl 0.25 % Injectable SolutionPSNeb6d8fee-def4-4c96-9972-695e8cea8ea810
1672917BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSNeb6d8fee-def4-4c96-9972-695e8cea8ea810
1672919BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSNeb6d8fee-def4-4c96-9972-695e8cea8ea810
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSNeb6d8fee-def4-4c96-9972-695e8cea8ea810
1724884BUPivacaine HCl 0.5 % in 30 ML InjectionPSNeb6d8fee-def4-4c96-9972-695e8cea8ea810
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSNeb6d8fee-def4-4c96-9972-695e8cea8ea810
1012391BUPivacaine HCl 0.75 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSNeb6d8fee-def4-4c96-9972-695e8cea8ea810
1725175Sensorcaine 0.25 % in 10 ML InjectionPSNeb6d8fee-def4-4c96-9972-695e8cea8ea810
1725177Sensorcaine 0.25 % in 30 ML InjectionPSNeb6d8fee-def4-4c96-9972-695e8cea8ea810
1012455Sensorcaine 0.25 % Injectable SolutionPSNeb6d8fee-def4-4c96-9972-695e8cea8ea810
1673298Sensorcaine 0.5 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSNeb6d8fee-def4-4c96-9972-695e8cea8ea810
1724881Sensorcaine 0.5 % in 10 ML InjectionPSNeb6d8fee-def4-4c96-9972-695e8cea8ea810
1724885Sensorcaine 0.5 % in 30 ML InjectionPSNeb6d8fee-def4-4c96-9972-695e8cea8ea810
1012457Sensorcaine 0.5 % Injectable SolutionPSNeb6d8fee-def4-4c96-9972-695e8cea8ea810
1012421Sensorcaine 0.75 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSNeb6d8fee-def4-4c96-9972-695e8cea8ea810
1673296Sensorcaine 5 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSNeb6d8fee-def4-4c96-9972-695e8cea8ea810
172517510 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Sensorcaine]SBDeb6d8fee-def4-4c96-9972-695e8cea8ea810
167329610 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection [Sensorcaine with Epinephrine]SBDeb6d8fee-def4-4c96-9972-695e8cea8ea810
172488110 ML bupivacaine hydrochloride 5 MG/ML Injection [Sensorcaine]SBDeb6d8fee-def4-4c96-9972-695e8cea8ea810
172517730 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Sensorcaine]SBDeb6d8fee-def4-4c96-9972-695e8cea8ea810
167329830 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection [Sensorcaine with Epinephrine]SBDeb6d8fee-def4-4c96-9972-695e8cea8ea810
172488530 ML bupivacaine hydrochloride 5 MG/ML Injection [Sensorcaine]SBDeb6d8fee-def4-4c96-9972-695e8cea8ea810
101242130 ML bupivacaine hydrochloride 7.5 MG/ML / epinephrine 0.005 MG/ML Injection [Sensorcaine with Epinephrine]SBDeb6d8fee-def4-4c96-9972-695e8cea8ea810
1012455bupivacaine hydrochloride 2.5 MG/ML Injectable Solution [Sensorcaine]SBDeb6d8fee-def4-4c96-9972-695e8cea8ea810
1012457bupivacaine hydrochloride 5 MG/ML Injectable Solution [Sensorcaine]SBDeb6d8fee-def4-4c96-9972-695e8cea8ea810
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDeb6d8fee-def4-4c96-9972-695e8cea8ea810
167291710 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML InjectionSCDeb6d8fee-def4-4c96-9972-695e8cea8ea810
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCDeb6d8fee-def4-4c96-9972-695e8cea8ea810
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDeb6d8fee-def4-4c96-9972-695e8cea8ea810
167291930 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML InjectionSCDeb6d8fee-def4-4c96-9972-695e8cea8ea810
172488430 ML bupivacaine hydrochloride 5 MG/ML InjectionSCDeb6d8fee-def4-4c96-9972-695e8cea8ea810
101239130 ML bupivacaine hydrochloride 7.5 MG/ML / epinephrine 0.005 MG/ML InjectionSCDeb6d8fee-def4-4c96-9972-695e8cea8ea810
1012396bupivacaine hydrochloride 2.5 MG/ML Injectable SolutionSCDeb6d8fee-def4-4c96-9972-695e8cea8ea810
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCDeb6d8fee-def4-4c96-9972-695e8cea8ea810
172517510 ML Sensorcaine 2.5 MG/ML InjectionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
172488110 ML Sensorcaine 5 MG/ML InjectionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
172517730 ML Sensorcaine 2.5 MG/ML InjectionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
172488530 ML Sensorcaine 5 MG/ML InjectionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1672917bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 10 ML InjectionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1672919bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 30 ML InjectionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1724884bupivacaine HCl 0.5 % in 30 ML InjectionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1012391bupivacaine HCl 0.75 % / epinephrine (as epinephrine bitartrate) 1:200,000 per 30 ML InjectionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1012396bupivacaine hydrochloride 0.25 % Injectable SolutionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1012455Sensorcaine 0.25 % Injectable SolutionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1673298Sensorcaine 0.5 % / epinephrine (as bitratrate) 1:200,000 in 30 mL InjectionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1012457Sensorcaine 0.5 % Injectable SolutionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1012455Sensorcaine 2.5 MG/ML Injectable SolutionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1673296Sensorcaine 5 % / EPINEPHrine 1:200,000 per 10 ML InjectionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1012457Sensorcaine 5 MG/ML Injectable SolutionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1012421Sensorcaine with Epinephrine 0.75 % / 1:200,000 (bupivacaine hydrochloride / epinephrine (as epinephrine bitartrate) ) per 30 ML InjectionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1725175Sensorcaine-MPF 0.25 % in 10 ML InjectionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1725177Sensorcaine-MPF 0.25 % in 30 ML InjectionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1724881Sensorcaine-MPF 0.5 % in 10 ML InjectionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1724885Sensorcaine-MPF 0.5 % in 30 ML InjectionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1012421Sensorcaine-MPF 0.75 % / epinephrine 1:200,000 per 30 ML InjectionSYeb6d8fee-def4-4c96-9972-695e8cea8ea810
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSN100201ad-6e4d-4e91-8b5c-621d0bf0dcc25
1012457Sensorcaine 0.5 % Injectable SolutionPSN100201ad-6e4d-4e91-8b5c-621d0bf0dcc25
1012457bupivacaine hydrochloride 5 MG/ML Injectable Solution [Sensorcaine]SBD100201ad-6e4d-4e91-8b5c-621d0bf0dcc25
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCD100201ad-6e4d-4e91-8b5c-621d0bf0dcc25
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSY100201ad-6e4d-4e91-8b5c-621d0bf0dcc25
1012457Sensorcaine 0.5 % Injectable SolutionSY100201ad-6e4d-4e91-8b5c-621d0bf0dcc25
1012457Sensorcaine 5 MG/ML Injectable SolutionSY100201ad-6e4d-4e91-8b5c-621d0bf0dcc25
1012396BUPivacaine HCl 0.25 % Injectable SolutionPSNe391f807-7699-6d82-e053-2a95a90ab6414
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSNe391f807-7699-6d82-e053-2a95a90ab6414
1012396bupivacaine hydrochloride 2.5 MG/ML Injectable SolutionSCDe391f807-7699-6d82-e053-2a95a90ab6414
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCDe391f807-7699-6d82-e053-2a95a90ab6414
1012396bupivacaine hydrochloride 0.25 % Injectable SolutionSYe391f807-7699-6d82-e053-2a95a90ab6414
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSYe391f807-7699-6d82-e053-2a95a90ab6414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-467-016332304670150 mL in 1 VIAL, MULTI-DOSE50 mlHistorical
63323-467-576332304675725 VIAL, MULTI-DOSE in 1 TRAY (63323-467-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-467-01) 2010-11-190000-00-00NoNoCurrent