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 20 of 47 · 937 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WALMART SALINESALINE NASAL (SODIUM CHLORIDE)WALMART STORES INC06906744-49a5-4bab-8539-af2d235df9e82025-10-28WarningsExact identifier
unii: 451W47IQ8X
SalineNASALPUBLIX SUPER MARKETS, INC19841567-9511-43d6-ba4e-d1e1bd3481a42025-10-28WarningsExact identifier
unii: 451W47IQ8X
NITROGENNITROGENClinical 1 Home Medical, Inc.4d7413b3-74f7-4439-91ab-bef2c3f27fda2025-10-28Exact identifier
unii: N762921K75
NitrogenNITROGENAero All Gas Companyfadb4118-fc02-4c66-aa7a-cf78a861602e2025-10-28Exact identifier
unii: N762921K75
NitrogenNITROGENFresno Oxygen & Welding Suppliers Inc80929f9d-93c1-430d-aba3-cdf99b2abd722025-10-28Exact identifier
unii: N762921K75
NitrogenNITROGENDuPuy Oxygen & Supply Company, Inc.6cf60077-dc91-41e5-8d6f-22589a66e6c52025-10-24Exact identifier
unii: N762921K75
Jacksons Cell Salts KALI MUR 6X 5KALI MURIATICUMZettl Health Inc.41ed34d0-94c3-ce79-e063-6294a90a08cb2025-10-24WarningsExact identifier
unii: 451W47IQ8X
NitrogenNITROGENHARTMAN BROTHERS, INC.123ca615-78ce-4bc8-bcae-168c4740c2302025-10-24Exact identifier
unii: N762921K75
NORMOSOL-M AND DEXTROSEDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATEICU Medical Inc.aba60c84-94d9-46d0-bdbb-25e0c4e8cc412025-10-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
miranda castros HEALING FOR INSECT BITES AND STINGSCALENDULA OFFICINALIS, CALADIUM SEGUINUM, LEDUM PALUSTRE, NATRUM MURIATICUM, PLANTAGO MAJOR, STAPHYSAGRIA, URTICA URENSMIRANDA CASTRO'S SHOP, LLC1f99d32e-2394-411a-e063-6294a90ac4542025-10-23WarningsExact identifier
unii: 451W47IQ8X
NitrogenNITROGENA-OX Welding Supply, LLCd810b2ee-0e0a-e952-e053-2a95a90afeca2025-10-23Exact identifier
unii: N762921K75
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical Inc.b96eb740-749a-4d3a-ae63-b8e3947cad302025-10-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
NitrogenNITROGENDepke Welding Supplies, Inc.12405e89-8a75-4c78-9e00-a3503fa408082025-10-21Exact identifier
unii: N762921K75
Sodium Chloride Normal SaltSODIUM CHLORIDEMethod Pharmaceuticalsce84727a-3677-4bf0-e053-2995a90a3ec82025-10-21WarningsExact identifier
unii: 451W47IQ8X
NitrogenNITROGENMetro Welding Supply Corporation7c83f51c-c44a-4850-9895-58eeb0b39ca82025-10-20Exact identifier
unii: N762921K75
WalgreensSODIUM CHLORIDEWalgreen Company21dfc2cf-65ae-c3fb-e063-6294a90a0a942025-10-17Exact identifier
unii: 451W47IQ8X
Homeopathic Tea Tree Oil LiceEUCALYPTUS GLOBULUS, NATRUM MURIATICUMDOLGENCORP, LLC0a0c2db2-7eeb-909c-e063-6394a90a7a902025-10-15WarningsExact identifier
unii: 451W47IQ8X
NITROGENNITROGENFlint Welding Supply Company4bd47792-3465-488d-b4d7-eafd5c83807e2025-10-13Exact identifier
unii: N762921K75
Saline AmpoulesSODIUM CHLORIDE 0.9%Trifecta Pharmaceuticals USA, LLC.ee18ef7c-bb5d-30ec-e053-2a95a90a964e2025-10-13WarningsExact identifier
unii: 451W47IQ8X
NitrogenNITROGENWesco Gas & Welding Supply, Inc.ea2a3b5d-f53f-49cd-9e43-708f69879cce2025-10-13Exact identifier
unii: N762921K75

Reported adverse events (FAERS/openFDA)#

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