🇺🇸
United States · US · US:59353-065_1d0f4d9e-7a5e-4320-96ca-da538aec0c2f
Korsuva
Orange BookUNIISPLATC V03AX04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerVifor (International), Inc.
CountryUS (United States)
ATC codeV03AX04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11593530651212 VIAL, SINGLE-USE in 1 TRAY (59353-065-12) / 1.3 mL in 1 VIAL, SINGLE-USE (59353-065-01)
Annotations
UNII (FDA Substance ID)
0P70AR5BYB
DIFELIKEFALIN ACETATE
RxCUI 2569090
Orange Book
N214916
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0P70AR5BYB",
"rxcui": "2569090",
"inchikey": "MZWHRPKAHCWTOI-KGURMGBCSA-N",
"display_name": "DIFELIKEFALIN ACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"0c7b81f2-0fd3-47cb-8b0f-185e07f19c87": {
"match": "brand_token",
"title": "KORSUVA (DIFELIKEFALIN) INJECTION, SOLUTION [VIFOR (INTERNATIONAL), INC.]",
"spl_version": "9",
"published_date": "2025-09-01"
}
},
"productid": "59353-065_1d0f4d9e-7a5e-4320-96ca-da538aec0c2f",
"productndc": "59353-065",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "214916",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)",
"product_no": "001",
"approval_date": "Aug 23, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIFELIKEFALIN ACETATE",
"proprietary_name": "Korsuva",
"active_ingred_unit": "ug/mL",
"application_number": "NDA214916",
"marketing_category": "NDA",
"nonproprietary_name": "difelikefalin",
"start_marketing_date": "20211101",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code V03AX04.
- ISKapruviaVifor Fresenius Medical Care Renal Pharma France*
- 🇨🇭Kapruvia
- PLKapruviaVifor Fresenius Medical Care Renal Pharma France
- NOKapruviaVifor Fresenius Medical Care Renal Pharma France
- DKKapruviaVifor Fresenius Medical Care Renal Pharma France
- FIKapruviaVifor Fresenius Medical Care Renal Pharma France
- FIKapruviaOrifarm Oy
- CZKAPRUVIAVifor Fresenius Medical Care Renal Pharma France, Paříž
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