NDC 59353-065-01 - Korsuva

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 59353-065
Requested NDC: 59353-065-01
Package NDCs from labels: 59353-065-01, 59353-065-12
Manufacturer: Vifor (International), Inc.
Effective date: 2025-08-26
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Korsuva - Vifor (International), Inc.	Vifor (International), Inc.	2025-08-26	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59353-065-01	Korsuva	1.3 mL in 1 VIAL, SINGLE-USE	INJECTION, SOLUTION	1.3		9
59353-065-12	Korsuva	12 in 1 TRAY	INJECTION, SOLUTION	12		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59353-065	KORSUVA (DIFELIKEFALIN) INJECTION, SOLUTION [VIFOR (INTERNATIONAL) INC.]	8	Current NDC, Legacy NDC, 2 package rows	20240802_0c7b81f2-0fd3-47cb-8b0f-185e07f19c87.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59353-065-01	ML - Milliliter	59353-065	c35b7f41-de09-48da-b113-636eb647c010	1	2022-04-06
59353-065-12	ML - Milliliter	59353-065	95990dd9-5fe4-4466-a04a-94a37e144ab8	1	2022-04-06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Korsuva	DIFELIKEFALIN	Vifor (International), Inc.	0c7b81f2-0fd3-47cb-8b0f-185e07f19c87	2025-08-26	Warnings, Adverse reactions	Exact identifier application number: NDA214916 ndc (package): 59353-065-01 ndc (package): 59353-065-12 ndc (product): 59353-065 ndc11 (package): 59353006501 rxcui: 2569100 rxcui: 2569094 spl id: 1d0f4d9e-7a5e-4320-96ca-da538aec0c2f spl set id: 0c7b81f2-0fd3-47cb-8b0f-185e07f19c87 unii: 0P70AR5BYB

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.