FDA.reportPublic FDA data

NDC 65174-200-01 - Drax Exametazime

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
65174-200
Requested NDC
65174-200-01
Package NDCs from labels
65174-200-01, 65174-200-05
Manufacturer
Jubilant DraxImage Inc., dba Jubilant Radiopharma | Jubilant HollisterStier General Partnership
Effective date
2024-12-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Drax Exametazime - Jubilant DraxImage Inc., dba Jubilant Radiopharma | Jubilant HollisterStier General PartnershipJubilant DraxImage Inc., dba Jubilant Radiopharma | Jubilant HollisterStier General Partnership2024-12-02Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65174-200-01Drax Exametazime1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,14
65174-200-05Drax Exametazime5 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65174-200DRAX EXAMETAZIME (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M EXAMETAZIME FOR LEUKOCYTE LABELING) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA]4Current NDC, Legacy NDC, 2 package rows20241208_fa7811f9-2803-4126-8037-8f3e56462f9c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65174-200-01EA - Each65174-2008741bff3-075f-4f11-a1d4-709c8768efc312024-04-05
65174-200-05EA - Each65174-2003883d260-f601-404a-8a5f-a584bff0612f12024-04-05

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 12 of 50 · 992 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NitrogenNITROGENLinde Puerto Rico B.V.4e5df6ce-06ef-498f-b064-b2b6e15219512025-12-31Exact identifier
unii: N762921K75
NitrogenNITROGENLinde Puerto Rico B.V.eb4d56b3-4869-44b1-a1ab-700d42c03c1f2025-12-31Exact identifier
unii: N762921K75
Immune BoostCHERRY PLUM, FERR PHOS, HORNBEAM, KALI SULPH, NAT MUR, OAK, OLIVE, THYMUS (CALF), ZINC MURSiddha Flower Essences LLCe8d44b65-47ef-ebc7-e053-2995a90a85832025-12-31WarningsExact identifier
unii: 451W47IQ8X
emotional detoxCALC PHOS, CALC SULPH, CASTANEA SATIVA, FLOS, ILEX AQUIFOLIUM, FLOS, KALI PHOS, NAT MUR, NAT PHOS, NAT SULPH, OLEA EUROPAEA, FLOS, ORNITHOGALUM UMBELLATUM, FLOSSiddha Flower Essences LLC385fb878-dd8f-40ae-82a3-874d6a6cceb22025-12-31WarningsExact identifier
unii: 451W47IQ8X
happy heartBROMUS RAMOSUS, FLOS, CALC FLUOR, CENTAURIUM UMBELLATUM, FLOS, FER PHOS, ILEX AQUIFOLIUM, FLOS, KALI PHOS, MAG PHOS, NAT MURSiddha Flower Essences LLCadb25966-b49a-48a9-a4ce-3ad7a2d7a7122025-12-31WarningsExact identifier
unii: 451W47IQ8X
digestAESCULUS HIPPOCASTANUM, BUD, CAL PHOS, CARPINUS BETULUS, FLOS, KALI PHOS, MAG PHOS, NAT MUR, NAT SULPH, ULMUS PROCERA, FLOSSiddha Flower Essences LLC99886d33-d8e0-4f58-89fa-e5071b30a98e2025-12-31WarningsExact identifier
unii: 451W47IQ8X
blood sugarCALC PHOS, CARPINUS BETULUS, FLOS, FERRUM PHOS, KALI PHOS, NAT MUR, NAT SULPH, OLEA EUROPAEA, FLOS, SILICEA, SINAPIS ARVENSIS, FLOSSiddha Flower Essences, LLC90ecd62b-c4bc-4bc4-a409-219929a49edb2025-12-31WarningsExact identifier
unii: 451W47IQ8X
mood and patienceCALC PHOS, CALC SULPH, CARPINUS BETULUS FLOS, FER PHOS, ILEX AQUIFOLIUM FLOS, IMPATIENS GLANDULIFERA FLOS, KALI PHOS, MAG PHOS, NAT MUR, NAT SULPHSiddha Flower Essences LLC03f55295-94f9-44f6-9386-ea2741a0f8be2025-12-31WarningsExact identifier
unii: 451W47IQ8X
sleepAESCULUS HIPPOCASTANUM, FLOS, FERRUM PHOS, KALI CARB, KALI PHOS, MAG PHOS, NAT MUR, POPULUS TERMULA, FLOS, PRUNUS CERASIFERA, FLOSSiddha Flower Essences LLCdc353895-3a58-475c-8afd-ab08b27b96c32025-12-31WarningsExact identifier
unii: 451W47IQ8X
throat and voiceCERATOSTIGMA WILLMOTTIANUM, FLOS, FERRUM PHOS, HOTTONIA PALUSTRIS, FLOS, KALI MUR, KALI PHOS, MAG PHOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT SULPH, SILICEASiddha Flower Essences LLC375ef37c-d5de-4762-a569-7304d98825202025-12-31WarningsExact identifier
unii: 451W47IQ8X
healthy hairCERTOSTIGMA WILLMOTTIANUM, FLOS, KALI SULPH, LARIX DECIDUA, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, SILICEASiddha Flower Essences LLC2b49fb7a-8d8b-4cef-8f8d-515c54451bfd2025-12-31WarningsExact identifier
unii: 451W47IQ8X
grief and lossCALC PHOS, CALC SULPH, CASTANEA SATIVA FLOS, IGNATIA AMARA, JUGLANS REGIA FLOS, KALI PHOS, NAT MUR, NAT SULPH, ORNITHOLAGUM UMBELLATUM FLOS, PHOS ACIDSiddha Flower Essences LLC1bb78196-303e-4c19-8bd9-d2add41ec52b2025-12-31WarningsExact identifier
unii: 451W47IQ8X
sightAESCULUS HIPPOCASTANUM, BUD, BROMUS RAMOSUS, FLOS, CALC FLUORICA, CALC PHOS, CALC SULPH, CLEMATIS VITALBA, FLOS, FERRUM PHOS, MAG PHOS, NAT MUR, SILICEASiddha Flower Essences LLCe6a5a50f-873e-4aa0-ad66-ccfa70c75cde2025-12-31WarningsExact identifier
unii: 451W47IQ8X
mind and memoryAESCULUS HIPPOCASTANUM FLOS, CALC PHOS, CALC SULPH, CLEMATIS VITALBA FLOS, KALI PHOS, MAG PHOS, NAT MUR, SCLERANTHUS ANNUUS FLOW, SILICEASiddha Flower Essences LLC0d35b9a2-2123-4c14-b0b8-f45f3820ee032025-12-31WarningsExact identifier
unii: 451W47IQ8X
energy and motivationCALC SULPH, GENTIANA AMARELLA FLOS, KALI PHOS, NAT MUR, NAT PHOS, NAT SULPH, OLEA EUROPEA FLOS, PHOS ACID, ULEX EUROPAEUS FLOSSiddha Flower Essences LLCaa69dd35-9866-40d7-9820-b01fc15be58a2025-12-31WarningsExact identifier
unii: 451W47IQ8X
youthful skinAESCULUS HIPPOCASTANUM, BUD, AGRIMONIA EUPATORIA, FLOS, CALC FLUORICA, CALC SULPH, FERRUM PHOS, KALI SULPH, MALUS PUMILA, FLOS, NAT MUR, SILICEASiddha Flower Essences LLC6f72f1b9-d627-4110-9546-13320e62c4652025-12-31WarningsExact identifier
unii: 451W47IQ8X
male balanceCENTARIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, KALI PHOS, LARIX DECIDUA, FLOS, LYCOPODIUM, NAT MUR, NAT PHOS, SILICEASiddha Flower Essences LLC61b7cfe0-1465-482b-97dd-8fbb8d420a932025-12-31WarningsExact identifier
unii: 451W47IQ8X
NitrogenNITROGENLinde Canada Inc.7fd42cc1-8e1e-43b3-981b-d0d6cf454f5a2025-12-30Exact identifier
unii: N762921K75
Helium Oxygen Nitrogen mixtureHELIUM OXYGEN NITROGEN MIXTURELinde Gas & Equipment Inc.619c58a9-7eae-450a-aa89-0027a388ce062025-12-30Exact identifier
unii: N762921K75
NitrogenNITROGENHaun Welding Supply, Inc.97ccccd8-4da7-f521-e053-2a95a90a0faf2025-12-29Exact identifier
unii: N762921K75

Reported adverse events (FAERS/openFDA)#

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