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United States · US · US:68516-3212_d13b6d66-7106-4a34-8521-1cf16d2578b9
Profilnine
SPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGRIFOLS USA, LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168516321221 KIT in 1 CARTON (68516-3212-2) * 10 mL in 1 VIAL (68516-3206-2) * 10 mL in 1 VIAL, GLASS (76297-002-12)
Annotations
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "INTRAVENOUS",
"spl_meta": {
"79821042-86a5-4a64-b621-76de0a0bbab2": {
"match": "brand_token",
"title": "PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]",
"spl_version": "33",
"published_date": "2026-04-10"
}
},
"productid": "68516-3212_d13b6d66-7106-4a34-8521-1cf16d2578b9",
"productndc": "68516-3212",
"dosage_form": "KIT",
"dea_schedule": null,
"product_type": "PLASMA DERIVATIVE",
"substance_name": null,
"proprietary_name": "Profilnine",
"active_ingred_unit": null,
"application_number": "BLA102476",
"marketing_category": "BLA",
"nonproprietary_name": "factor ix complex",
"start_marketing_date": "19810720",
"active_numerator_strength": null
}Access this data programmatically
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