FDA.reportPublic FDA data

Drax Exametazime

Product NDC
65174-200
11-digit product format
651740200
Labeler code
65174
Product ID
65174-200_9799f139-0c16-4cf0-8a7d-e9668ec3f146
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Jubilant DraxImage Inc., dba Jubilant Radiopharma
Application
NDA208870
Marketing category
NDA
Marketing start
2017-08-17
Substance
TECHNETIUM TC-99M EXAMETAZIME
Active strength
.5 mg/1
Pharmacologic classes
Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Drax Exametazime
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TECHNETIUM TC-99M EXAMETAZIME.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3B744AG22N

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2265993-8bd7-4a7d-bf41-09c31b647f03Product name120230719

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 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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65174-200-01651740200011 in 1 VIALHistorical
65174-200-05651740200055 VIAL in 1 CARTON (65174-200-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65174-200-01) 5 vial2017-08-170000-00-00NoNoCurrent