FDA.reportPublic FDA data

SENSORCAINE

Product NDC
63323-472
Requested package NDC
63323-472-17
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63323-47263323-472-17DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070554-001SENSORCAINEBUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE / INJECTIONAP1986-05-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A070554-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A070554-001SENSORCAINE0.75%INJECTABLE / INJECTIONAP1986-05-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A070554-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENSORCAINEBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb2023-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070554
application number: ANDA070554
ndc (package): 63323-472-17
ndc (product): 63323-472
ndc11 (package): 63323047217

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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
30Q7KI53AKInternal UNII lookup
7TQO7W3VT8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1012377Internal RxNorm lookup
1012384Internal RxNorm lookup
1012413Internal RxNorm lookup
1012417Internal RxNorm lookup
1724786Internal RxNorm lookup
1724787Internal RxNorm lookup
1724809Internal RxNorm lookup
1724810Internal RxNorm lookup
1867594Internal RxNorm lookup
1867596Internal RxNorm lookup
1867618Internal RxNorm lookup
1867620Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bc61a9a6-0a4e-48a9-b908-e5e66b9f23ebAvailable on FDA.report

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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
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