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United States · US · US:68982-261_5be10bd2-a785-7f3b-0d28-d066cd5f7d24
Balfaxar
UNIISPLATC B01AD
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOctapharma USA Inc
CountryUS (United States)
ATC codeB01AD
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1168982261011 VIAL, GLASS in 1 CARTON (68982-261-01) / 20 mL in 1 VIAL, GLASS (68982-261-81)
- ndc1168982261021 VIAL, GLASS in 1 CARTON (68982-261-02) / 40 mL in 1 VIAL, GLASS (68982-261-82)
Annotations
UNII (FDA Substance ID)
6U90Y1795T
COAGULATION FACTOR IX HUMAN
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6U90Y1795T",
"rxcui": null,
"inchikey": null,
"display_name": "COAGULATION FACTOR IX HUMAN",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"68fa4f90-8b01-6498-4140-e0be5247c3fe": {
"match": "brand_token",
"title": "BALFAXAR (PROTHROMBIN COMPLEX CONCENTRATE (HUMAN)) POWDER, FOR SOLUTION [OCTAPHARMA USA INC]",
"spl_version": "4",
"published_date": "2023-11-30"
}
},
"productid": "68982-261_5be10bd2-a785-7f3b-0d28-d066cd5f7d24",
"productndc": "68982-261",
"dosage_form": "POWDER, FOR SOLUTION",
"dea_schedule": null,
"product_type": "PLASMA DERIVATIVE",
"substance_name": "COAGULATION FACTOR IX HUMAN; COAGULATION FACTOR VII HUMAN; COAGULATION FACTOR X HUMAN; PROTEIN C; PROTEIN S HUMAN; PROTHROMBIN",
"proprietary_name": "Balfaxar",
"active_ingred_unit": "[iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL",
"application_number": "BLA125776",
"marketing_category": "BLA",
"nonproprietary_name": "Prothrombin Complex Concentrate (Human)",
"start_marketing_date": "20231130",
"active_numerator_strength": "25.5; 16.5; 24; 22; 22; 26"
}Related drugs
Other records sharing ATC code B01AD.
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- IEMetalyse 8 000 units (40 mg) powder and solvent for solution for injectionBoehringer Ingelheim International GmbH
- GBVaridase Topical 125,000unit powder vialsWyeth Pharmaceuticals
- GBVaridase Topical 125,000unit powder vials and diluentWyeth Pharmaceuticals
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