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 49 of 51 · 1,008 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Blues - Mood - EmotionsANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGONewton Laboratories, Inc.79890e75-dfac-0262-e053-2a91aa0a5ce52020-11-24WarningsExact identifier
unii: 451W47IQ8X
Blues - Mood - EmotionsANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGONewton Laboratories, Inc.798ab5a2-7464-8e9d-e053-2a91aa0acc982020-11-24WarningsExact identifier
unii: 451W47IQ8X
Cold Hands - FeetHISTAMINUM HYDROCHLORICUM,THYROIDINUM, ACONITUM NAP., ARSENICUM ALB., BRYONIA, CACTUS, CALC. FLUOR., CEANOTHUS, CINCHONA, CONVALLARIA, DIGITALIS, GELSEMIUM, GLONOINUM, HYDROCOYLE, KALI CARB., LACHESIS, NAJA, NAT CARB., NAT MUR., NUX VOM., PHOSPHORUS, PULLSATILLA, RHUS TOXICODENDRON, STROPHANTHUS HISPIDUS, SULPHUR, ECHINACEANewton Laboratories, Inc.7a2b4f28-2128-a8b2-e053-2a91aa0a24022020-11-24WarningsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEAsclemed USA, Inc.afac6cc5-1ced-4639-b6f6-86f40ef5c30e2020-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GUNA ALLERGYADRENALINUM - ALLIUM CEPA - AMMONIUM CARBONICUM - APIS MELLIFICA - ARGENTUM NITRICUM - ARSENICUM ALBUM - CUPRUM ACETICUM - GALPHIMIA GLAUCA - GLANDULA SUPRARENALIS SUIS - HISTAMINUM HYDROCHLORICUM - LUFFA OPERCULATA - MATRICARIA CHAMOMILLA - MUCOSA NASALIS SUIS - NATRUM MURIATICUM - SABADILLA - SCILLA MARITIMA -Guna spaae6bd80d-2c70-1a3f-e053-2a95a90a26522020-10-23WarningsExact identifier
unii: 451W47IQ8X
InterSolPLATELET ADDITIVE 3Fenwal, Inc.a00c4a93-cde2-4753-81f7-0d6fee9fb6902020-10-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
BUPIVICAINE HYDROCHLORIDEBUPIVICAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst99857946-6084-1bbd-e053-2a95a90af58c2020-10-06Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
GUNA FLAM RELIEFACONITUM NAPELLUS - APIS MELLIFERA - ARNICA MONTANA WHOLE - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - MATRICARIA CHAMOMILLA WHOLE - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - ECHINACEA ANGUSTIFOLIA - FERRIC PHOSPHATE - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - PORK LIVER - RANCID BEEF - SUS SCROFA PITUITARY GLAND -Guna spaaf5a9c74-e1c7-6574-e053-2995a90a3d102020-09-15WarningsExact identifier
unii: 2968PHW8QP
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstac0fd44a-3f39-8d7e-e053-2995a90afeec2020-08-04Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
CardioplegicCALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM CHLORIDEBaxter Healthcare Corporation1fd50ce5-2799-4c26-81da-02cf0578dd9e2020-06-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta62b71db-8ba2-6f6b-e053-2a95a90a29d12020-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LACTATED RINGERS AND DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEHF Acquisition Co LLC, DBA HealthFirsta62cf623-9b8a-37e0-e053-2995a90add5b2020-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Hay FeverAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, ALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, AMMONIUM CARBONICUM, ARALIA RACEMOSA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CALLUNA VULGARIS, FLOS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CISTUS CANADENSIS, DROSERA, DULCAMARA, EUPATORIUM PERFOLIATUM, EUPHRASIA OFFICINALIS, FAGUS SYLVATICA, FRAXINUS AMERICANA, GELSEMIUM SEMPERVIRENSNewton Laboratories, Inc.a6045b91-d361-2731-e053-2a95a90a97722020-05-18WarningsExact identifier
unii: 451W47IQ8X
Isolyte SSODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEB. Braun Medical Inc.7e8fe27f-ff82-48c1-9bf6-3c589c8e985d2020-05-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DEXTROSE AND SODIUM CHLORIDEDEXTROSE MONOHYDRATE, SODIUM CHLORIDEFresenius Kabi USA, LLCb825c9c4-f2fb-4a4a-9d8c-fb020ad07e932020-04-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEAsclemed USA, Inc.3eefbefe-78ae-4f2d-9be6-3f79eadcff862020-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta2b8220f-e33a-51c3-e053-2995a90a07342020-04-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta2bba76a-08ce-6902-e053-2995a90ab9c92020-04-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose and Electrolyte No. 48SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Companyb283a454-0c20-4fbf-92d3-dae1f3cd3cad2020-02-13Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporationfbc01464-8885-4075-af41-911ffec5ae922020-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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