FDA.reportPublic FDA data

SENSORCAINE

Product NDC
63323-472
11-digit product format
633230472
Labeler code
63323
Product ID
63323-472_cc1f6507-eb3e-4398-a1d3-0c56a2099e6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; RETROBULBAR
Labeler
Fresenius Kabi USA, LLC
Application
ANDA070554
Marketing category
ANDA
Marketing start
2010-11-19
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
7.5 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
Brand name suffix
MPF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE7.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii30Q7KI53AK, 7TQO7W3VT8
Rxcui1012377, 1012384, 1012413, 1012417, 1724786, 1724787, 1724809, 1724810, 1867594, 1867596, 1867618, 1867620

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
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
a831e694-3663-4a83-82be-6c309429f750Product name220200608
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-472-01SENSORCAINEMPF30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION307
63323-472-03SENSORCAINEMPF10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION107
63323-472-17SENSORCAINEMPF25 in 1 TRAYINJECTION, SOLUTION257
63323-472-37SENSORCAINEMPF25 in 1 TRAYINJECTION, SOLUTION257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-472-01ML - Milliliter63323-472c80ec71b-5e22-4442-bfa7-680a2d9a272912022-12-07
63323-472-03ML - Milliliter63323-472d55b90ab-f67f-4735-a7bd-1e58502f196012022-04-06
63323-472-17ML - Milliliter63323-472eb8b4441-a708-44a0-895b-fc23777d15b812012-07-24
63323-472-33ML - Milliliter63323-47256027130-de10-4c49-bef2-bf2b3f4ba0d112012-07-24
63323-472-37ML - Milliliter63323-4725c74ff5f-2fe8-4015-ab09-1bf688f1f68012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
EPINEPHRINE BITARTRATEACTIVE INGREDIENT30Q7KI53AKSENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
BUPIVACAINEACTIVE MOIETYY8335394ROSENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
EPINEPHRINEACTIVE MOIETYYKH834O4BHSENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBSENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CSENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-472SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]7Current NDC, Legacy NDC, 4 package rows20230712_bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1867594BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSNbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1867596BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSNbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1012377BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 Injectable SolutionPSNbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1012384BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable SolutionPSNbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1724787BUPivacaine HCl 0.75 % in 10 ML InjectionPSNbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1724786BUPivacaine HCl 0.75 % in 30 ML InjectionPSNbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1867618Sensorcaine 0.25 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSNbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1867620Sensorcaine 0.25 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSNbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1012413Sensorcaine 0.25 % / EPINEPHrine 1:200,000 Injectable SolutionPSNbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1012417Sensorcaine 0.5 % / EPINEPHrine 1:200,000 Injectable SolutionPSNbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1724809Sensorcaine 0.75 % in 10 ML InjectionPSNbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1724810Sensorcaine 0.75 % in 30 ML InjectionPSNbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
186761810 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection [Sensorcaine with Epinephrine]SBDbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
172480910 ML bupivacaine hydrochloride 7.5 MG/ML Injection [Sensorcaine]SBDbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
186762030 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection [Sensorcaine with Epinephrine]SBDbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
172481030 ML bupivacaine hydrochloride 7.5 MG/ML Injection [Sensorcaine]SBDbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1012413bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution [Sensorcaine with Epinephrine]SBDbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1012417bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution [Sensorcaine with Epinephrine]SBDbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
186759410 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML InjectionSCDbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
172478710 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCDbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
186759630 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML InjectionSCDbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
172478630 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCDbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1012377bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injectable SolutionSCDbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1012384bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable SolutionSCDbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
172480910 ML Sensorcaine 7.5 MG/ML InjectionSYbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
172481030 ML Sensorcaine 7.5 MG/ML InjectionSYbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1867594bupivacaine HCl 0.25 % / epinephrine (as bitartrate) 1:200,000 per 10 mL InjectionSYbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1867596bupivacaine HCl 0.25 % / epinephrine 1:200,000 per 30 ML InjectionSYbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1724787bupivacaine HCl 0.75 % in 10 ML InjectionSYbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1724786bupivacaine HCl 0.75 % in 30 ML InjectionSYbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1724786bupivacaine HCl 225 MG per 30 ML InjectionSYbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1724787bupivacaine HCl 75 MG per 10 ML InjectionSYbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1012377bupivacaine hydrochloride 0.25 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable SolutionSYbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1012384bupivacaine hydrochloride 0.5 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable SolutionSYbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1012413Sensorcaine 0.25 % / EPINEPHrine 1:200,000 Injectable SolutionSYbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1867618Sensorcaine 0.25 % / EPINEPHrine 1:200,000 per 10 ML InjectionSYbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1867620Sensorcaine 0.25 % / EPINEPHrine 1:200,000 per 30 ML InjectionSYbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1012413Sensorcaine with Epinephrine 0.25/1:200000 (bupivacaine hydrochloride / epinephrine (as epinephrine bitartrate) ) Injectable SolutionSYbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1012417Sensorcaine with Epinephrine 0.5/1:200000 (bupivacaine hydrochloride / epinephrine (as epinephrine bitartrate) ) Injectable SolutionSYbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1012417Sensorcaine-MPF 0.5 % / epinephrine 1:200,000 Injectable SolutionSYbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1724809Sensorcaine-MPF 0.75 % in 10 ML InjectionSYbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7
1724810Sensorcaine-MPF 0.75 % in 30 ML InjectionSYbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-472-016332304720130 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical
63323-472-036332304720310 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
63323-472-176332304721725 VIAL, SINGLE-DOSE in 1 TRAY (63323-472-17) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-472-03) 2010-11-190000-00-00NoNoCurrent
63323-472-376332304723725 VIAL, SINGLE-DOSE in 1 TRAY (63323-472-37) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-472-01) 2010-11-190000-00-00NoNoCurrent