korsuva

Generic: difelikefalin

Labeler: vifor (international), inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name korsuva
Generic Name difelikefalin
Labeler vifor (international), inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

difelikefalin acetate 50 ug/mL

Manufacturer
Vifor (International), Inc.

Identifiers & Regulatory

Product NDC 59353-065
Product ID 59353-065_1d0f4d9e-7a5e-4320-96ca-da538aec0c2f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214916
Listing Expiration 2026-12-31
Marketing Start 2021-11-01

Pharmacologic Class

Classes
kappa opioid receptor agonist [epc] opioid kappa receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59353065
Hyphenated Format 59353-065

Supplemental Identifiers

RxCUI
2569094 2569100
UNII
0P70AR5BYB

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name korsuva (source: ndc)
Generic Name difelikefalin (source: ndc)
Application Number NDA214916 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 ug/mL
source: ndc
Packaging
  • 12 VIAL, SINGLE-USE in 1 TRAY (59353-065-12) / 1.3 mL in 1 VIAL, SINGLE-USE (59353-065-01)
source: ndc

Packages (1)

59353-065-12 12 VIAL, SINGLE-USE in 1 TRAY (59353-065-12) / 1.3 mL in 1 VIAL, SINGLE-USE (59353-065-01)

Ingredients (1)

difelikefalin acetate (50 ug/mL)

Linked Drug Pages (1)

Korsuva ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1d0f4d9e-7a5e-4320-96ca-da538aec0c2f", "openfda": {"unii": ["0P70AR5BYB"], "rxcui": ["2569094", "2569100"], "spl_set_id": ["0c7b81f2-0fd3-47cb-8b0f-185e07f19c87"], "manufacturer_name": ["Vifor (International), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 VIAL, SINGLE-USE in 1 TRAY (59353-065-12)  / 1.3 mL in 1 VIAL, SINGLE-USE (59353-065-01)", "package_ndc": "59353-065-12", "marketing_start_date": "20211101"}], "brand_name": "Korsuva", "product_id": "59353-065_1d0f4d9e-7a5e-4320-96ca-da538aec0c2f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Kappa Opioid Receptor Agonist [EPC]", "Opioid kappa Receptor Agonists [MoA]"], "product_ndc": "59353-065", "generic_name": "difelikefalin", "labeler_name": "Vifor (International), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Korsuva", "active_ingredients": [{"name": "DIFELIKEFALIN ACETATE", "strength": "50 ug/mL"}], "application_number": "NDA214916", "marketing_category": "NDA", "marketing_start_date": "20211101", "listing_expiration_date": "20261231"}