🇺🇸
United States · US · US:65174-200_9799f139-0c16-4cf0-8a7d-e9668ec3f146
Drax Exametazime
In shortageOrange BookUNIISPLATC V09AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJubilant DraxImage Inc., dba Jubilant Radiopharma
CountryUS (United States)
ATC codeV09AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165174200055 VIAL in 1 CARTON (65174-200-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65174-200-01)
Annotations
UNII (FDA Substance ID)
3B744AG22N
TECHNETIUM TC-99M EXAMETAZIME
RxCUI 1431726
Orange Book
N208870
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Technetium TC-99M Pyrophosphate Kit Injection
Raw payload (JSON)
{
"unii": {
"unii": "3B744AG22N",
"rxcui": "1431726",
"inchikey": "ZLRVWFDVJWKAIL-LXMACRGBSA-M",
"display_name": "TECHNETIUM TC-99M EXAMETAZIME",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"fa7811f9-2803-4126-8037-8f3e56462f9c": {
"match": "brand_token",
"title": "DRAX EXAMETAZIME (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M EXAMETAZIME FOR LEUKOCYTE LABELING) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA]",
"spl_version": "4",
"published_date": "2024-12-09"
}
},
"productid": "65174-200_9799f139-0c16-4cf0-8a7d-e9668ec3f146",
"productndc": "65174-200",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "208870",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "N/A",
"product_no": "001",
"approval_date": "Aug 17, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TECHNETIUM TC-99M EXAMETAZIME",
"shortage_reason": "Technetium TC-99M Pyrophosphate Kit Injection",
"shortage_status": "current",
"proprietary_name": "Drax Exametazime",
"active_ingred_unit": "mg/1",
"application_number": "NDA208870",
"marketing_category": "NDA",
"nonproprietary_name": "Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling",
"start_marketing_date": "20170817",
"active_numerator_strength": ".5"
}Related drugs
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- FICeretecGE Healthcare AS
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- 🇺🇸CERETECMedi-Physics Inc. dba GE Healthcare.
- NLCeretec 0,5 mg kit voor radiofarmaceutische preparaatGE Healthcare B.V.
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