FDA.reportPublic FDA data

SENSORCAINE

Product NDC
63323-463
11-digit product format
633230463
Labeler code
63323
Product ID
63323-463_cc1f6507-eb3e-4398-a1d3-0c56a2099e6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE
Dosage form
INJECTION, SOLUTION
Route
PERINEURAL
Labeler
Fresenius Kabi USA, LLC
Application
ANDA070968
Marketing category
ANDA
Marketing start
2010-11-19
Substance
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength
5; .005 mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
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
EPINEPHRINE BITARTRATE.005 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
63323-463-01SENSORCAINE50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION507
63323-463-57SENSORCAINE25 in 1 TRAYINJECTION, SOLUTION257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-463-01ML - Milliliter63323-4637aa7c5aa-745e-4eda-96be-cf6bae25bae012020-03-10
63323-463-57ML - Milliliter63323-463c0bcd771-c2b9-4f60-ab62-3248a9642b0f12012-07-24

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
63323-463SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]7Current NDC, Legacy NDC, 2 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
63323-463-016332304630150 mL in 1 VIAL, MULTI-DOSE50 mlHistorical
63323-463-576332304635725 VIAL, MULTI-DOSE in 1 TRAY (63323-463-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-463-01) 2010-11-190000-00-00NoNoCurrent