🇺🇸
United States · US · US:65857-505_d54cd404-317c-4a70-a22d-1667550ab5bc
Kit for the Preparation of Technetium Tc 99m Medronate
In shortageOrange BookUNIISPLATC V09BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCardinal Health 414, LLC
CountryUS (United States)
ATC codeV09BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11658575051010 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (65857-505-10)
Annotations
UNII (FDA Substance ID)
X89XV46R07
TECHNETIUM TC-99M MEDRONATE
RxCUI 1488818
Orange Book
N018107
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Technetium TC-99M Pyrophosphate Kit Injection
Raw payload (JSON)
{
"unii": {
"unii": "X89XV46R07",
"rxcui": "1488818",
"inchikey": "GEJDKFSIZBOWEL-SGNQUONSSA-J",
"display_name": "TECHNETIUM TC-99M MEDRONATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"54608807-4df6-49ba-b065-59a19ef224c4": {
"match": "brand_token",
"title": "KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE (TECHNETIUM TC 99M MEDRONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CARDINAL HEALTH 414, LLC]",
"spl_version": "5",
"published_date": "2025-09-10"
}
},
"productid": "65857-505_d54cd404-317c-4a70-a22d-1667550ab5bc",
"productndc": "65857-505",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "018107",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "N/A",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TECHNETIUM TC-99M MEDRONATE",
"shortage_reason": "Technetium TC-99M Pyrophosphate Kit Injection",
"shortage_status": "current",
"proprietary_name": "Kit for the Preparation of Technetium Tc 99m Medronate",
"active_ingred_unit": "mg/1",
"application_number": "NDA018107",
"marketing_category": "NDA",
"nonproprietary_name": "technetium tc 99m medronate",
"start_marketing_date": "20201201",
"active_numerator_strength": "20"
}Related drugs
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