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 16 of 47 · 937 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NitrogenNITROGENMinneapolis Oxygen Companyc3fdbc5c-da70-4cbd-bdee-eddb4d852b262025-12-01Exact identifier
unii: N762921K75
Walgreen SalineNASALWALGREENS CO.ee264d8b-0bb2-472a-907c-6a6291f154cd2025-11-26WarningsExact identifier
unii: 451W47IQ8X
NITROGENNITROGENLampton Welding Supply Company, Inc125eedfb-8ab0-42b3-8393-7e8b9313020b2025-11-26Exact identifier
unii: N762921K75
NITROGENNITROGENVolunteer Welding Supply Incc4c1b8a0-d957-44f8-a7d1-aefe9b251b662025-11-26Exact identifier
unii: N762921K75
NitrogenNITROGENSuper Gas, Inc.80a178d8-7173-4e7a-ace9-7fe3fd0e07242025-11-26Exact identifier
unii: N762921K75
NitrogenNITROGENGeneral Air Service & Supply Co8e44ea92-d052-438a-b850-ccd147906e472025-11-26Exact identifier
unii: N762921K75
NitrogenNITROGENYoung Welding Supply, Inc86565775-ba7a-4e84-a9d9-72806a871b592025-11-26Exact identifier
unii: N762921K75
NitrogenNITROGENDale Oxygen And Acetylene Service, Incb4d03108-9837-495b-bf0d-2bb929cb7e392025-11-25Exact identifier
unii: N762921K75
NitrogenNITROGENMississippi Welders Supply Company, Inc.02b3fd81-4792-4dd6-9efb-1c3d58132a882025-11-25Exact identifier
unii: N762921K75
NITROGENNITROGENMedical-Technical Gases, Inc.eb3cfc21-907d-ae13-e053-2a95a90a15c62025-11-25Exact identifier
unii: N762921K75
NitrogenNITROGENOxarc, LLC74d62331-0e9e-4983-90e9-4de506fcfdcf2025-11-25Exact identifier
unii: N762921K75
NitrogenNITROGENS. J. Smith Co., Inc.d85670e1-a5e8-466d-bf58-9d6c75b2a6912025-11-25Exact identifier
unii: N762921K75
Natural Eyes Floaters ReliefCHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEATRP Company445dc831-195e-4b25-e063-6294a90a6efd2025-11-24WarningsExact identifier
unii: 451W47IQ8X
NitrogenNITROGENFULLERTON WELDING SUPPLY74aa9180-1ea2-01fc-e053-2a91aa0aa6e12025-11-21Exact identifier
unii: N762921K75
NitrogenNITROGENFULLERTON WELDING SUPPLY74a94613-d970-1596-e053-2991aa0a32902025-11-21Exact identifier
unii: N762921K75
NitrogenNITROGENGeneral Cryogenic Technologies LLCa415b0af-c894-430c-9c6f-4cc10210843d2025-11-21Exact identifier
unii: N762921K75
NitrogenNITROGENVictor Welding Supply Company1ec8aa75-a12c-4000-a6a2-ae42c14fff562025-11-21Exact identifier
unii: N762921K75
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, ONOSMODIUM VIRGINIANUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.1ca43c82-62b0-4191-81a4-27f7f94109dd2025-11-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEWalgreen Companyd112a344-33cc-41d3-bae6-492631ebdba72025-11-19WarningsExact identifier
unii: 451W47IQ8X
NitrogenNITROGENMesser Gas Puerto Rico, Inc4f5ce040-eb19-1dd8-41cf-1f9438b1936c2025-11-18WarningsExact identifier
unii: N762921K75

Reported adverse events (FAERS/openFDA)#

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