FDA.reportPublic FDA data

NDC 63323-488-01 - Xylocaine MPF

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
63323-488
Requested NDC
63323-488-01
Package NDCs from labels
63323-488-07, 63323-488-37, 63323-488-03, 63323-488-31, 63323-488-01, 63323-488-17
Manufacturer
Fresenius Kabi USA, LLC | Fresenius Kabi Austria
Effective date
2021-08-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Xylocaine MPF - Fresenius Kabi USA, LLC | Fresenius Kabi AustriaFresenius Kabi USA, LLC | Fresenius Kabi Austria2021-08-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-488-01XylocaineMPF10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1013
63323-488-03XylocaineMPF30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION3013
63323-488-07XylocaineMPF30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION3013
63323-488-17XylocaineMPF25 in 1 TRAYINJECTION, SOLUTION2513
63323-488-31XylocaineMPF5 in 1 CARTONINJECTION, SOLUTION513
63323-488-37XylocaineMPF25 in 1 TRAYINJECTION, SOLUTION2513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-488XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]13Current NDC, Legacy NDC, 6 package rows20210831_ba082c2f-64f4-419d-9c88-74f203316e17.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-488-07ML - Milliliter63323-4883ae53bc4-ca37-4a40-ae51-697ff7f942a312021-05-05
63323-488-17ML - Milliliter63323-48818b9fc6a-2197-402d-ba0b-67a7dd50f4a012012-07-24
63323-488-31ML - Milliliter63323-4884c06246a-44de-4b6a-960f-f9e1d7a1095612012-07-24
63323-488-37ML - Milliliter63323-488b5b7fef8-47c2-4529-a097-63972a6a38bc12012-07-24
63323-488-92ML - Milliliter63323-488b0dc8021-2eb0-4ef4-b7b9-6abd2da2a41d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EPINEPHRINE BITARTRATEACTIVE INGREDIENT30Q7KI53AKXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
EPINEPHRINEACTIVE MOIETYYKH834O4BHXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
LIDOCAINEACTIVE MOIETY98PI200987XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6

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 53 of 57 · 1,128 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CENTROCODEAMERICAN GINSENG, ADENOSINE TRIPHOSPHATE, CORTICOTROPIN, ALFALFA, BOS TAURUS HYPOTHALAMUS, PHYTOLACCA AMERICANA ROOT, BOS TAURUS PITUITARY GLAND POSTERIOR, THYROID UNSPECIFIED, IODINE, SILICON DIOXIDE, OSTER SHELL CALCIUM CARBONATE CRUDE, STRYCHNOS IGNATII SEED, IRIDIUM, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, SELENIUM, URANYL NITRATE HEXAHYDRATE.Natural Creations, Inc.e5bbe9ec-7602-4de5-907a-7047c10198b62021-11-15WarningsExact identifier
unii: 451W47IQ8X
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
application number: NDA006488
ndc (package): 63323-489-21
ndc (package): 63323-491-01
ndc (package): 63323-486-27
ndc (package): 63323-486-57
ndc (package): 63323-487-17
ndc (package): 63323-483-01
ndc (package): 63323-485-27
ndc (package): 63323-495-09
ndc (package): 63323-488-07
ndc (package): 63323-492-57
ndc (package): 63323-485-03
ndc (package): 63323-487-07
ndc (package): 63323-491-57
ndc (package): 63323-482-01
ndc (package): 63323-492-07
ndc (package): 63323-489-17
ndc (package): 63323-486-01
ndc (package): 63323-486-17
ndc (package): 63323-489-01
ndc (package): 63323-483-27
ndc (package): 63323-482-05
ndc (package): 63323-482-03
ndc (package): 63323-489-02
ndc (package): 63323-485-01
ndc (package): 63323-487-37
ndc (package): 63323-489-27
ndc (package): 63323-481-57
ndc (package): 63323-484-57
ndc (package): 63323-487-03
ndc (package): 63323-486-02
ndc (package): 63323-482-17
ndc (package): 63323-488-37
ndc (package): 63323-488-17
ndc (package): 63323-482-57
ndc (package): 63323-492-31
ndc (package): 63323-488-03
ndc (package): 63323-495-07
ndc (package): 63323-495-27
ndc (package): 63323-486-05
ndc (package): 63323-483-57
ndc (package): 63323-487-31
ndc (package): 63323-492-09
ndc (package): 63323-492-04
ndc (package): 63323-488-01
ndc (package): 63323-483-03
ndc (package): 63323-488-31
ndc (package): 63323-485-57
ndc (package): 63323-481-01
ndc (package): 63323-489-03
ndc (package): 63323-487-01
ndc (package): 63323-492-03
ndc (package): 63323-482-27
ndc (package): 63323-492-37
ndc (package): 63323-495-04
ndc (package): 63323-492-27
ndc (product): 63323-482
ndc (product): 63323-487
ndc (product): 63323-491
ndc (product): 63323-492
ndc (product): 63323-481
ndc (product): 63323-486
ndc (product): 63323-495
ndc (product): 63323-485
ndc (product): 63323-489
ndc (product): 63323-483
ndc (product): 63323-488
ndc (product): 63323-484
ndc11 (package): 63323048801
rxcui: 1867997
rxcui: 1010673
rxcui: 1737757
rxcui: 1737758
rxcui: 1010751
rxcui: 1737343
rxcui: 1737570
rxcui: 1010900
rxcui: 1867944
rxcui: 1010755
rxcui: 1868029
rxcui: 1010035
rxcui: 1010033
rxcui: 1867996
rxcui: 1737569
rxcui: 1867993
rxcui: 1737345
rxcui: 1737761
rxcui: 1010688
rxcui: 1737762
rxcui: 1867938
rxcui: 1010759
rxcui: 1867940
rxcui: 1010902
rxcui: 1010671
rxcui: 1010692
rxcui: 1737562
rxcui: 1737571
rxcui: 1868028
rxcui: 1737566
rxcui: 1737567
rxcui: 1010745
rxcui: 1010749
rxcui: 1737563
rxcui: 1867992
rxcui: 1737568
rxcui: 1010763
rxcui: 1867943
spl id: ea480a68-5927-4278-9deb-2956961da428
spl set id: ba082c2f-64f4-419d-9c88-74f203316e17
unii: 30Q7KI53AK
unii: EC2CNF7XFP
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

Reported adverse events (FAERS/openFDA)#

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