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United States · US · US:58394-635_3b0657cb-0070-4c64-b72c-2518178805e7
BeneFIX
SPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWyeth BioPharma Division of Wyeth Pharmaceuticals LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1158394635031 KIT in 1 CARTON (58394-635-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) * 5 mL in 1 VIAL, SINGLE-USE (58394-135-03)
Annotations
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"85faa5bc-cee5-4ef1-8d80-bdbcb7eba1e4": {
"match": "brand_token",
"title": "BENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS LLC]",
"spl_version": "45",
"published_date": "2025-02-27"
}
},
"productid": "58394-635_3b0657cb-0070-4c64-b72c-2518178805e7",
"productndc": "58394-635",
"dosage_form": "KIT",
"dea_schedule": null,
"product_type": "PLASMA DERIVATIVE",
"substance_name": null,
"proprietary_name": "BeneFIX",
"active_ingred_unit": null,
"application_number": "BLA103677",
"marketing_category": "BLA",
"nonproprietary_name": "coagulation factor ix (recombinant)",
"start_marketing_date": "19970201",
"active_numerator_strength": null
}Access this data programmatically
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