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 17 of 50 · 992 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
NitrogenNITROGENMesser Gas Puerto Rico, Inca64bb3c9-3947-d2f3-a219-24b58ec41abc2025-11-18Exact identifier
unii: N762921K75
NitrogenNITROGENMesser Gas Puerto Rico, Inc2c2cdad0-833e-cc29-bc5e-7d92161c68e62025-11-18WarningsExact identifier
unii: N762921K75
NitrogenNITROGENAll Gas & Welding Supplies Co., Inc.f43540c0-741c-78c3-e053-2995a90aa2d42025-11-18Exact identifier
unii: N762921K75
NitrogenNITROGENA & B Welding Supply Co.d8143272-2594-f3f4-e053-2a95a90abf6e2025-11-18Exact identifier
unii: N762921K75
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCce0c8c6f-734a-400f-9b60-a3b1e263f25f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
NitrogenNITROGENRoberts Oxygen Company, Inc273511c2-2b84-4373-a0e5-3961eb19af8c2025-11-17Exact identifier
unii: N762921K75
NitrogenNITROGENRoberts Oxygen Company, Inc863f2711-582f-4ccb-aae8-9bb18fa4df532025-11-17Exact identifier
unii: N762921K75
NitrogenNITROGENRoberts Oxygen Company, Inc.2bed6bd8-086e-ee30-e063-6394a90ad4202025-11-17Exact identifier
unii: N762921K75
Sodium ChlorideSODIUM CHLORIDE TABLETSKesin Pharma Corporation2f107592-10c5-ef3b-e063-6394a90a7c0a2025-11-17WarningsExact identifier
unii: 451W47IQ8X
NitrogenNITROGENDelille Oxygen Companyb82f163b-c913-431d-88cf-8b6e08d1b42a2025-11-17Exact identifier
unii: N762921K75
NITROGENNITROGENKeen Compressed Gas Co. Inc.ce23d008-6b12-4937-9b87-fea423ac49a82025-11-17Exact identifier
unii: N762921K75
NITROGENNITROGENHolston Gases, Incad17ae2e-033c-4bb0-804b-538f9350a09f2025-11-14Exact identifier
unii: N762921K75
NITROGENNITROGENSuperior Welding Supply Co8c3be9ad-0e95-43db-924d-d31ccea61f892025-11-14Exact identifier
unii: N762921K75
NitrogenNITROGENGeneral Distributing Companye2ee1489-0037-42ed-8fb3-0a566e3a2c342025-11-14Exact identifier
unii: N762921K75
ALUMIZENGARLIC, AVENA SATIVA FLOWERING TOP, BERBERIS VULGARIS ROOT BARK, ARCTIUM LAPPA ROOT, PHYTOLACCA AMERICANA ROOT, SOLIDAGO VIRGAUREA FLOWERING TOP, ALUMINUM OXIDE, SILVER NITRATE, BARIUM CARBONATE, BERYLLIUM, CADMIUM, COPPER, HYDROFLUORIC ACID, INDIUM, IODINE, LITHIUM CARBONATE, MERCURIUS SOLUBILIS, NICKEL CARBONATE HYDROXIDE TETRAHYDRATE, NITROUS OXIDE, LEAD, SELENIUM, STRONTIUM CARBONATE, TITANIUM, ARSENIC TRIOXIDE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED.Natural Creations, Inc.4760ab09-1141-4944-b840-804ae6d86d2d2025-11-13WarningsExact identifier
unii: 451W47IQ8X
BLISTER HPJUGLANS CINEREA BRANCH BARK/ROOT BARK, POTASSIUM IODIDE, LYCOPODIUM CLAVATUM SPORE, MERCURY, SODIUM CHLORIDE, NITRIC ACID, PHOSPHORUS, RANUNCULUS BULBOSUS, TOXICODENDRON PUBESCENS LEAF, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAFY TWIG.Natural Creations, Inc.e76f05e7-6d7b-4d2e-ba26-bf776bf0e6572025-11-13WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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