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United States · US · US:65174-179_92a1bc37-cc23-4498-ad61-29347c3876dc
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJubilant DraxImage Inc., dba Jubilant Radiopharma
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165174179011 KIT in 1 PACKAGE (65174-179-01) * 3 mL in 1 VIAL (65174-046-01) * 3 mL in 1 VIAL (65174-047-01) * 10 mL in 1 VIAL (65174-131-01)
Annotations
Orange Book
A213516
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"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": "65174-179_92a1bc37-cc23-4498-ad61-29347c3876dc",
"productndc": "65174-179",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "213516",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "N/A",
"product_no": "001",
"approval_date": "Nov 9, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Kit for the Preparation of Technetium Tc 99m Sulfur Colloid",
"active_ingred_unit": null,
"application_number": "ANDA213516",
"marketing_category": "ANDA",
"nonproprietary_name": "Technetium Tc 99m Sulfur Colloid Kit",
"start_marketing_date": "20231204",
"active_numerator_strength": null
}Access this data programmatically
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