FDA.reportPublic FDA data

Korsuva

Product NDC
59353-065
11-digit product format
593530065
Labeler code
59353
Product ID
59353-065_1d0f4d9e-7a5e-4320-96ca-da538aec0c2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
difelikefalin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Vifor (International), Inc.
Application
NDA214916
Marketing category
NDA
Marketing start
2021-11-01
Substance
DIFELIKEFALIN ACETATE
Active strength
50 ug/mL
Pharmacologic classes
Kappa Opioid Receptor Agonist [EPC], Opioid kappa Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Korsuva
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIFELIKEFALIN ACETATE50 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0P70AR5BYB
Rxcui2569094, 2569100

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
61e84e80-22a5-4f21-9d15-2782825a51adProduct name120220224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59353-065-01Korsuva1.3 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION1.39
59353-065-12Korsuva12 in 1 TRAYINJECTION, SOLUTION129

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59353-065-01ML - Milliliter59353-065c35b7f41-de09-48da-b113-636eb647c01012022-04-06
59353-065-12ML - Milliliter59353-06595990dd9-5fe4-4466-a04a-94a37e144ab812022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59353-065KORSUVA (DIFELIKEFALIN) INJECTION, SOLUTION [VIFOR (INTERNATIONAL) INC.]8Current NDC, Legacy NDC, 2 package rows20240802_0c7b81f2-0fd3-47cb-8b0f-185e07f19c87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2569094difelikefalin 65 MCG in 1.3 ML InjectionPSN0c7b81f2-0fd3-47cb-8b0f-185e07f19c879
2569100KORSUVA 65 MCG in 1.3 ML InjectionPSN0c7b81f2-0fd3-47cb-8b0f-185e07f19c879
25691001.3 ML difelikefalin 0.05 MG/ML Injection [Korsuva]SBD0c7b81f2-0fd3-47cb-8b0f-185e07f19c879
25690941.3 ML difelikefalin 0.05 MG/ML InjectionSCD0c7b81f2-0fd3-47cb-8b0f-185e07f19c879
25691001.3 ML Korsuva 0.05 MG/ML InjectionSY0c7b81f2-0fd3-47cb-8b0f-185e07f19c879
2569094difelikefalin 65 MCG per 1.3 ML InjectionSY0c7b81f2-0fd3-47cb-8b0f-185e07f19c879
2569100Korsuva 50 MCG (equivalent to difelikefalin acetate 58.3 MCG) per 1 ML InjectionSY0c7b81f2-0fd3-47cb-8b0f-185e07f19c879
2569100Korsuva 65 MCG per 1.3 ML InjectionSY0c7b81f2-0fd3-47cb-8b0f-185e07f19c879

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59353-065-01593530065011.3 mL in 1 VIAL, SINGLE-USE1.3 mlHistorical
59353-065-125935300651212 VIAL, SINGLE-USE in 1 TRAY (59353-065-12) / 1.3 mL in 1 VIAL, SINGLE-USE (59353-065-01) 2021-11-010000-00-00NoNoCurrent