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 32 of 54 · 1,061 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health Sterile Saline MistSODIUM CHLORIDECVS Pharmacy6f1fe980-ca09-401d-aed6-d3d3387cc49a2024-12-18WarningsExact identifier
unii: 451W47IQ8X
Household DetoxALLIUM SATIVUM, ALUMINA, ANTIPYRINUM, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, DIETHYLSTILBESTROL, DIOXIN, FOLLICULINUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PETROLEUM, PHENACETINUM, PTELEA TRIFOLIATA, SODIUM CARBOXYMETHYL CELLULOSE, TEFLONDeseret Biologicals, Inc.7f79058a-c35a-429a-be3c-4cff1d6570872024-12-13WarningsExact identifier
unii: A2I8C7HI9T
Mast Cell ProHYDRASTIS CANADENSIS, ASCORBICUM ACIDUM, CINCHONA OFFICINALIS, KIDNEY (SUIS), THIAMINUM HYDROCHLORICUM, URTICA DIOICA, APIS MELLIFICA, ARSENICUM ALBUM, BOVISTA, CARBOLICUM ACIDUM, COFFEA CRUDA, HISTAMINUM HYDROCHLORICUM, LACHESIS MUTUS, LEDUM PALUSTRE, NUX VOMICA, OXALICUM ACIDUM, PHOSPHORUS, RHUS TOX, SARCOLACTICUM ACIDUM, SECALE CORNUTUM, SEPIA, SEROTONIN (HYDROCHLORIDE), SULPHUR, THUJA OCCIDENTALIS, VENUS MERCENARIA, ACONITUM NAPELLUS, CALADIUM SEGUINUM, IGNATIA AMARA, NATRUM MURIATICUM,Energique, Inc.5cd31e1d-0312-48d1-9ecd-d01c6fe3b6722024-12-11WarningsExact identifier
unii: 451W47IQ8X
Junior MovesANACARDIUM, BRYONIA, MAG MUR, NAT MUR, PLUMB METSilver Star Brands822d5481-7854-3fe7-e053-2a91aa0abf552024-12-03WarningsExact identifier
unii: 451W47IQ8X
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS LUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOS, STAPHYSAG, STRAMONIUMSilver Star Brands9d75666e-3214-2bab-e053-2a95a90af7192024-12-03WarningsExact identifier
unii: QTT17582CB
Migo-EaseACONITUM NAP, LYCOPODIUM, NAT MUR, NUX VOM, PULSATILLASilver Star Brands816837f5-4487-657d-e053-2991aa0a78f42024-12-03WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Company464c2d78-5c88-4668-a039-56dd3c1c9b202024-12-03Exact identifier
unii: 451W47IQ8X
XX Health ProLACHESIS, NAT MUR, PULSATILLA, SEPIA, SULPHURSilver Star Brands4d11a65e-696a-0727-e054-00144ff88e882024-12-02WarningsExact identifier
unii: 451W47IQ8X
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d41602-9dcb-eaa8-e063-6394a90a7cfa2024-11-26WarningsExact identifier
unii: 451W47IQ8X
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d4ddaf-9c07-a7fc-e063-6394a90adc0b2024-11-26WarningsExact identifier
unii: 451W47IQ8X
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d5997b-1cae-41c2-e063-6394a90ac74a2024-11-26WarningsExact identifier
unii: 451W47IQ8X
SENSORCAINE MPFBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCb671015d-f620-4930-a890-5e27a40ae42f2024-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA070966
ndc (product): 63323-468
rxcui: 1867596
rxcui: 1867620
rxcui: 1867618
rxcui: 1867594
spl id: b671015d-f620-4930-a890-5e27a40ae42f
spl set id: b671015d-f620-4930-a890-5e27a40ae42f
unii: 30Q7KI53AK
unii: 7TQO7W3VT8
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation37063a49-6b45-4167-875d-49c9dac3f79b2024-11-20WarningsExact identifier
unii: 451W47IQ8X
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHuons Co., Ltd.2dc693df-3218-4a90-b3f7-21e80966a8512024-11-20Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACID MONOHYDRATEPAI Holdings, LLC dba PAI Pharmace42122f-8087-471f-b0a3-5524bdbd45262024-11-19Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Articaine Hydrochloride and EpinephrineARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATEBurkhart Dental Supply Co., Inc4f11bb06-c71b-4d96-9baa-2a17ad473a052024-11-18Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
SENSORCAINE MPFBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCb6bfc04a-1868-4630-9ca1-8c027af97ce32024-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
TRICITRATESPOTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATEPAI Holdings, LLC dba PAI Pharma2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad2024-11-15Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Sal de Uvas PicotCITRIC ACID MONOHYDRATE AND SODIUM BICARBONATERB Health Mexico, S.A. de C.V.151b9bc9-1a6e-4401-ae58-4b4210ab45052024-11-15WarningsExact identifier
unii: 2968PHW8QP
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Company99a15716-bbb9-4e33-a48d-20c58b81f3922024-11-13Exact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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