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 47 of 51 · 1,008 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OHM-ANXARGENTUM NITRICUM, AURUM METALLICUM, AVENA SATIVA, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, IGNATIA AMARA, MOSCHUS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, STANNUM METALLICUM, VALERIANA OFFICINALISOHM PHARMA INC.f743b690-8f79-4e60-81cd-e3e2825a1ec82021-11-15WarningsExact identifier
unii: 451W47IQ8X
Hydrate 2BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUANatural Creations, Inc52cb98dc-6858-42bf-9c54-d20fb607dfbb2021-11-12WarningsExact identifier
unii: 451W47IQ8X
Adrenal and DHEAARALIA QUINQUEFOLIA, ASHWAGANDHA, AVENA SATIVA, CARDUUS MARIANUS, DHEA, GLANDULA SUPRARENALIS SUIS, L-ARGININE, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, RHODIOLA.ProBLEN44991952-c440-4a33-9423-a9369c8bab702021-10-22WarningsExact identifier
unii: 451W47IQ8X
Dr. Talbots Daily Allergy ReliefALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUMTalbot's Pharmaceuticals Family Products, LLC.91c2795d-4cde-6e2c-e053-2995a90a00962021-10-05WarningsExact identifier
unii: 451W47IQ8X
Solucion InterSolSOLUCION ADITIVA PARA PLAQUETAS 3Fenwal, Inc.d5eaf5f4-67d3-4475-af9a-f5b0f882f5d12021-10-04Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
NATRUM MURIATICUMNATRUM MURIATICUMRxhomeo Private Limited d.b.a. Rxhomeo, Inc520edb18-5f2a-4448-ba53-83408a839e1f2021-09-02WarningsExact identifier
unii: 451W47IQ8X
XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCba082c2f-64f4-419d-9c88-74f203316e172021-08-25Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
Lactated Ringers IrrigationSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDEB. Braun Medical Inc.0db56c7a-2b8f-4593-8591-2c481c92b2cf2021-08-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium Chloride for IrrigationSODIUM CHLORIDE FOR IRRIGATIONB. Braun Medical Inc.5bd9b176-0402-4a3f-a6b4-c3f393fc092a2021-08-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
FungisodeARSENICUM ALBUM, BERBERIS VULGARIS, CALCAREA CARBONICA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, ECHINACEA PURPUREA, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NITRICUM ACIDUM, OXALICUM ACIDUM, SEPIA OFFICINALIS, SULPHURSeroyal USA55c5dfc4-3757-6ac2-e054-00144ff88e882021-07-22WarningsExact identifier
unii: QTT17582CB
0.9% SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstc755e41b-acba-7234-e053-2995a90aff0f2021-07-17Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Melange combinationCALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEASeroyal USA0a071fbf-0075-4479-e054-00144ff8d46c2021-07-14WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC4a655cde-283f-4ec8-a3d9-5f539c55c2042021-05-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCed8fd0c1-ac42-4267-877e-ceadf3831c902021-04-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dr. Talbots Vital 12CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA, ZINC GLUCTalbot's Pharmaceuticals Family Products, LLCc10bb804-8169-63da-e053-2a95a90a83062021-04-28WarningsExact identifier
unii: 451W47IQ8X
Dr. Talbots Infant Daily Allergy ReliefALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUMTalbot's Pharmaceuticals Family Products, LLCc0963200-67dd-6349-e053-2a95a90adde12021-04-22WarningsExact identifier
unii: 451W47IQ8X
CLINIMIX ELEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSEBaxter Healthcare Company8469d6fb-d6ef-476f-8cc3-0905192de0a82021-04-13Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEMedical Purchasing Solutions, LLCc3f8e83c-4fb9-91da-e053-2a95a90abd632021-04-12Adverse reactionsExact identifier
unii: 451W47IQ8X
CVS Health Sterile Saline Mist Live BetterSODIUM CHLORIDECVS Pharmacyccc3ab8c-b22f-420d-869b-f2a65b8c71802021-03-13WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporationaeaed9cb-b629-4019-88d2-a916179427de2021-02-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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