Home NDC 79802-200 Rezurock
Product NDC 79802-200
11-digit product format 798020200
Labeler code 79802
Product ID 79802-200_65249371-3fc5-4a85-a999-9ed367b8dd73
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name belumosudil
Dosage form TABLET
Route ORAL
Labeler Kadmon Pharmaceuticals, LLC
Application NDA214783
Marketing category NDA
Marketing start 2021-07-16
Substance BELUMOSUDIL
Active strength 200 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N214783-001 REZUROCK BELUMOSUDIL MESYLATE EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214783-001 10183931 2033-10-07 U-3246 2021-11-17 N214783-001 10183931 2033-10-07 U-4260 2021-11-17 N214783-001 10696660 2033-10-07 U-3246 2021-11-17 N214783-001 10696660 2033-10-07 U-4260 2021-11-17 N214783-001 8357693 2034-06-20 U-4259 Drug substance, Drug product 2021-11-17 N214783-001 11311541 2035-04-09 U-3369 2022-05-25 N214783-001 12097202 2042-07-14 U-4014 2024-10-24
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214783-001 NCE 2026-07-16 N214783-001 ODE-362 2028-07-16
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 2026-09-14 22:38:34 2026-08 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 181 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N214783-001 10183931 2033-10-07 U-4260 2021-11-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214783-001 10183931 2033-10-07 U-3246 2021-11-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214783-001 10696660 2033-10-07 U-4260 2021-11-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214783-001 10696660 2033-10-07 U-3246 2021-11-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214783-001 8357693 2034-06-20 U-4259 Drug substance, Drug product 2021-11-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214783-001 11311541 2035-04-09 U-3369 2022-05-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214783-001 12097202 2042-07-14 U-4014 2024-10-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214783-001 10183931 2033-10-07 U-4260 2021-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214783-001 10183931 2033-10-07 U-3246 2021-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214783-001 10696660 2033-10-07 U-4260 2021-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214783-001 10696660 2033-10-07 U-3246 2021-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214783-001 8357693 2034-06-20 U-4259 Drug substance, Drug product 2021-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214783-001 11311541 2035-04-09 U-3369 2022-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214783-001 12097202 2042-07-14 U-4014 2024-10-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214783-001 10183931 2033-10-07 U-4260 2021-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214783-001 10183931 2033-10-07 U-3246 2021-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214783-001 10696660 2033-10-07 U-4260 2021-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214783-001 10696660 2033-10-07 U-3246 2021-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214783-001 8357693 2034-06-20 U-4259 Drug substance, Drug product 2021-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214783-001 11311541 2035-04-09 U-3369 2022-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214783-001 12097202 2042-07-14 U-4014 2024-10-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214783-001 10183931 2033-10-07 U-4260 2021-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214783-001 10183931 2033-10-07 U-3246 2021-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214783-001 10696660 2033-10-07 U-4260 2021-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214783-001 10696660 2033-10-07 U-3246 2021-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214783-001 8357693 2034-06-20 U-4259 Drug substance, Drug product 2021-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214783-001 11311541 2035-04-09 U-3369 2022-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214783-001 12097202 2042-07-14 U-4014 2024-10-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214783-001 8357693 2029-10-30 U-3247 Drug substance, Drug product 2021-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214783-001 10183931 2033-10-07 U-3246 2021-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214783-001 10696660 2033-10-07 U-3246 2021-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214783-001 11311541 2035-04-09 U-3369 2022-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214783-001 12097202 2042-07-14 U-4014 2024-10-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214783-001 8357693 2029-10-30 U-3247 Drug substance, Drug product 2021-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214783-001 10183931 2033-10-07 U-3246 2021-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214783-001 10696660 2033-10-07 U-3246 2021-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214783-001 11311541 2035-04-09 U-3369 2022-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214783-001 12097202 2042-07-14 U-4014 2024-10-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214783-001 8357693 2029-10-30 U-3247 Drug substance, Drug product 2021-11-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214783-001 10183931 2033-10-07 U-3246 2021-11-17 b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 70 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Rezurock
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BELUMOSUDIL 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 834YJF89WO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2564031 Internal RxNorm lookup 2564037 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 79802-200-30 Rezurock 30 in 1 BOTTLE TABLET 30 11 79802-200-30 Rezurock 1 in 1 CARTON TABLET 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79802-200 REZUROCK (BELUMOSUDIL) TABLET [KADMON PHARMACEUTICALS, LLC] 9 Current NDC, Legacy NDC, 2 package rows 20250430_102e4ef4-7f84-4e34-8df1-479c24d1575d.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 79802-200-30 79802020030 1 BOTTLE in 1 CARTON (79802-200-30) / 30 TABLET in 1 BOTTLE 1 bottle 2021-07-16 0000-00-00 No No Current