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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

  • ndc11
    6517420005
    5 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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