drax exametazime

Generic: kit for the preparation of technetium tc 99m exametazime for leukocyte labeling

Labeler: jubilant draximage inc., dba jubilant radiopharma
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name drax exametazime
Generic Name kit for the preparation of technetium tc 99m exametazime for leukocyte labeling
Labeler jubilant draximage inc., dba jubilant radiopharma
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

technetium tc-99m exametazime .5 mg/1

Manufacturer
Jubilant DraxImage Inc., dba Jubilant Radiopharma

Identifiers & Regulatory

Product NDC 65174-200
Product ID 65174-200_9799f139-0c16-4cf0-8a7d-e9668ec3f146
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208870
Listing Expiration 2026-12-31
Marketing Start 2017-08-17

Pharmacologic Class

Established (EPC)
radioactive diagnostic agent [epc]
Mechanism of Action
radiopharmaceutical activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65174200
Hyphenated Format 65174-200

Supplemental Identifiers

UNII
3B744AG22N
NUI
N0000177914 N0000000205

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name drax exametazime (source: ndc)
Generic Name kit for the preparation of technetium tc 99m exametazime for leukocyte labeling (source: ndc)
Application Number NDA208870 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 5 VIAL in 1 CARTON (65174-200-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65174-200-01)
source: ndc

Packages (1)

65174-200-05 5 VIAL in 1 CARTON (65174-200-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65174-200-01)

Ingredients (1)

technetium tc-99m exametazime (.5 mg/1)

Linked Drug Pages (1)

Drax Exametazime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9799f139-0c16-4cf0-8a7d-e9668ec3f146", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["3B744AG22N"], "spl_set_id": ["fa7811f9-2803-4126-8037-8f3e56462f9c"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["Jubilant DraxImage Inc., dba Jubilant Radiopharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL in 1 CARTON (65174-200-05)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65174-200-01)", "package_ndc": "65174-200-05", "marketing_start_date": "20170817"}], "brand_name": "Drax Exametazime", "product_id": "65174-200_9799f139-0c16-4cf0-8a7d-e9668ec3f146", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "65174-200", "generic_name": "Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling", "labeler_name": "Jubilant DraxImage Inc., dba Jubilant Radiopharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Drax Exametazime", "active_ingredients": [{"name": "TECHNETIUM TC-99M EXAMETAZIME", "strength": ".5 mg/1"}], "application_number": "NDA208870", "marketing_category": "NDA", "marketing_start_date": "20170817", "listing_expiration_date": "20261231"}