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United States · US · US:65857-450_9a68964f-0f50-414d-a7c9-29b6677df463
Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCardinal Health 414, LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165857450051 KIT in 1 CARTON (65857-450-05) / 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65857-400-01) * 1 INJECTION, SOLUTION in 1 VIAL (65857-401-45)
Annotations
Orange Book
N202207
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": "65857-450_9a68964f-0f50-414d-a7c9-29b6677df463",
"productndc": "65857-450",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "202207",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "N/A",
"product_no": "001",
"approval_date": "Mar 13, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)",
"active_ingred_unit": null,
"application_number": "NDA202207",
"marketing_category": "NDA",
"nonproprietary_name": "tilmanocept",
"start_marketing_date": "20170920",
"active_numerator_strength": null
}Access this data programmatically
Query Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.