Home NDC 59353-065 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214916-001 KORSUVA DIFELIKEFALIN ACETATE EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214916-001 10017536 2027-11-12 U-3204 Drug substance 2021-09-20 N214916-001 10138270 2027-11-12 U-3204 2021-09-20 N214916-001 10793596 2027-11-12 U-3204 Drug substance, Drug product 2021-09-20 N214916-001 7713937 2027-11-12 U-3204 Drug substance, Drug product 2021-09-20 N214916-001 7727963 2027-11-12 U-3204 Drug substance, Drug product 2021-09-20 N214916-001 8217007 2027-11-12 U-3204 2021-09-20 N214916-001 8236766 2027-11-12 U-3204 2021-09-20 N214916-001 8486894 2027-11-12 U-3204 2021-09-20 N214916-001 8536131 2027-11-12 U-3204 Drug substance, Drug product 2021-09-20 N214916-001 9334305 2027-11-12 U-3204 2021-09-20 N214916-001 9359399 2027-11-12 U-3204 2021-09-20 N214916-001 7402564 2032-11-12 U-3204 Drug substance, Drug product 2021-09-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214916-001 NCE 2026-08-23
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214916-001 KORSUVA EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-23 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 11 · 408 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N214916-001 10017536 2027-11-12 U-3204 Drug substance 2021-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214916-001 10138270 2027-11-12 U-3204 2021-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214916-001 10793596 2027-11-12 U-3204 Drug substance, Drug product 2021-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214916-001 7713937 2027-11-12 U-3204 Drug substance, Drug product 2021-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214916-001 7727963 2027-11-12 U-3204 Drug substance, Drug product 2021-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214916-001 8217007 2027-11-12 U-3204 2021-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214916-001 8236766 2027-11-12 U-3204 2021-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214916-001 8486894 2027-11-12 U-3204 2021-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214916-001 8536131 2027-11-12 U-3204 Drug substance, Drug product 2021-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214916-001 9334305 2027-11-12 U-3204 2021-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214916-001 9359399 2027-11-12 U-3204 2021-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214916-001 7402564 2032-11-12 U-3204 Drug substance, Drug product 2021-09-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214916-001 10017536 2027-11-12 U-3204 Drug substance 2021-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214916-001 10138270 2027-11-12 U-3204 2021-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214916-001 10793596 2027-11-12 U-3204 Drug substance, Drug product 2021-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214916-001 7402564 2027-11-12 U-3204 Drug substance, Drug product 2021-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214916-001 7713937 2027-11-12 U-3204 Drug substance, Drug product 2021-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214916-001 7727963 2027-11-12 U-3204 Drug substance, Drug product 2021-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214916-001 8217007 2027-11-12 U-3204 2021-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214916-001 8236766 2027-11-12 U-3204 2021-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214916-001 8486894 2027-11-12 U-3204 2021-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214916-001 8536131 2027-11-12 U-3204 Drug substance, Drug product 2021-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214916-001 9334305 2027-11-12 U-3204 2021-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214916-001 9359399 2027-11-12 U-3204 2021-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214916-001 10017536 2027-11-12 U-3204 Drug substance 2021-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214916-001 10138270 2027-11-12 U-3204 2021-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214916-001 10793596 2027-11-12 U-3204 Drug substance, Drug product 2021-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214916-001 7402564 2027-11-12 U-3204 Drug substance, Drug product 2021-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214916-001 7713937 2027-11-12 U-3204 Drug substance, Drug product 2021-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214916-001 7727963 2027-11-12 U-3204 Drug substance, Drug product 2021-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214916-001 8217007 2027-11-12 U-3204 2021-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214916-001 8236766 2027-11-12 U-3204 2021-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214916-001 8486894 2027-11-12 U-3204 2021-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214916-001 8536131 2027-11-12 U-3204 Drug substance, Drug product 2021-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214916-001 9334305 2027-11-12 U-3204 2021-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214916-001 9359399 2027-11-12 U-3204 2021-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214916-001 10017536 2027-11-12 U-3204 Drug substance 2021-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214916-001 10138270 2027-11-12 U-3204 2021-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214916-001 10793596 2027-11-12 U-3204 Drug substance, Drug product 2021-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214916-001 7402564 2027-11-12 U-3204 Drug substance, Drug product 2021-09-20 6a471c1ec25d…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Korsuva
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIFELIKEFALIN ACETATE 50 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0P70AR5BYB Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2569094 Internal RxNorm lookup 2569100 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# 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
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59353-065-01 59353006501 1.3 mL in 1 VIAL, SINGLE-USE 1.3 ml Historical 59353-065-12 59353006512 12 VIAL, SINGLE-USE in 1 TRAY (59353-065-12) / 1.3 mL in 1 VIAL, SINGLE-USE (59353-065-01) 2021-11-01 0000-00-00 No No Current