FDA.reportPublic FDA data

NDC 63323-461-01 - SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63323-461
Requested NDC
63323-461-01
Package NDCs from labels
63323-461-01, 63323-461-57
Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Effective date
2024-01-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BUPIVACAINE HYDROCHLORIDE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-01-30HUMAN PRESCRIPTION DRUG LABEL
SENSORCAINE MPF - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2023-04-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-461-01SENSORCAINE50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION507
63323-461-57SENSORCAINE25 in 1 TRAYINJECTION, SOLUTION257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-461SENSORCAINE 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-461-01ML - Milliliter63323-46157ba37a9-3a24-42da-a55f-443914af525912021-06-02
63323-461-57ML - Milliliter63323-461832b75a3-bb7e-4cd3-a1a3-1d99f175d18e12012-07-24

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

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 22 of 54 · 1,061 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDENextgen Pharmaceuticals LLC28f79c75-82d2-4912-81fc-a723b5ccf4c12025-07-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEFosun Pharma USA Inc.3a996abe-0bb9-4590-e063-6394a90a0b602025-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEProPharma Distribution386c23fd-1691-98b2-e063-6294a90ab0702025-07-18Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEProPharma Distribution3868864f-4f46-d2a1-e063-6394a90a65d52025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: 451W47IQ8X
HerpaOneGRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIGAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions6b196d97-6446-4651-97ef-6615cf3e31732025-07-11WarningsExact identifier
unii: 451W47IQ8X
POTASSIUM CHLORIDE IN SODIUM CHLORIDESODIUM CHLORIDE AND POTASSIUM CHLORIDEB. Braun Medical Inc.ecc38772-246a-46c4-b42a-b9b81124f27f2025-07-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Leader Sinus Wash Saline Refill PacketsSODIUM BICARBONATE, SODIUM CHLORIDECardinal Health, 110 dba LEADERfb192a6d-318e-4d2b-89b6-42ac023e4fbd2025-07-09WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.0d59a04a-32e6-485b-b638-a1e6c09e96422025-07-09Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Schuessler Tissue Salts Nat Mur Fluid Balance 9NATRUM MURIATICUMMartin & Pleasance Pty Ltd0b21c366-fff6-4754-a671-35481ec2c4bd2025-07-07WarningsExact identifier
unii: 451W47IQ8X
Normal SaltSODIUM CHLORIDETwin Med LLCdc82ff0f-8600-373a-e053-2995a90a75052025-07-03WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride Normal SaltSODIUM CHLORIDEAdvanced Rx LLC40f471b7-27cf-4ad4-aef6-cc9d0623ddd92025-07-02WarningsExact identifier
unii: 451W47IQ8X
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC0956bd7c-d46f-483a-bf2c-9e11c6111ebf2025-07-02Exact identifier
unii: 451W47IQ8X
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCb79ef556-37b3-4fd0-8589-c633033be9df2025-07-02Exact identifier
unii: 451W47IQ8X
ParasodeARTEMISIA VULGARIS ROOT, CHELIDONIUM MAJUS WHOLE, PUNICA GRANATUM ROOT BARK, SPIGELIA ANTHELMIA WHOLE, KRAMERIA LAPPACEA ROOT, ARSENIC TRIOXIDE, IRON, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ARTEMISIA CINA PRE-FLOWERING TOP, SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS, GRAPHITE, CALOMEL, SODIUM CHLORIDE, AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEZorex0ed722dc-cd25-4a15-b3f8-052cc7bcd9ec2025-07-01WarningsExact identifier
unii: 451W47IQ8X
EXTRANEALICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEVantive US Healthcare LLCd5b85158-b0d6-4855-9d07-8d1b3ad9ab712025-06-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporation958d35f0-6834-43be-a700-fa58f38b4c192025-06-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
InterSolPLATELET ADDITIVE 3Fenwal, Inc.17dec820-1b57-4ac9-82a8-419cab664a2f2025-06-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
HAIR STIMPEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINORThe Wellness Center for Research and Education, Inc.8ecc05ff-ed5a-4157-9100-1c7912686f072025-06-06WarningsExact identifier
unii: 451W47IQ8X
MBM 7 LungCOCCUS CACTI, LUNG (SUIS), IGNATIA AMARA, CAUSTICUM, NATRUM MURIATICUMThe Wellness Center for Research and Education, Inc.6eb49fb5-485c-4b48-b231-4db88ebe20df2025-06-04WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.