FDA.reportPublic FDA data

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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N214783-001REZUROCKBELUMOSUDIL MESYLATEEQ 200MG BASETABLET / ORALRLD, RS2021-07-16

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N214783-001101839312033-10-07U-32462021-11-17
N214783-001101839312033-10-07U-42602021-11-17
N214783-001106966602033-10-07U-32462021-11-17
N214783-001106966602033-10-07U-42602021-11-17
N214783-00183576932034-06-20U-4259Drug substance, Drug product2021-11-17
N214783-001113115412035-04-09U-33692022-05-25
N214783-001120972022042-07-14U-40142024-10-24

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N214783-001NCE2026-07-16
N214783-001ODE-3622028-07-16

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N214783-001REZUROCKEQ 200MG BASETABLET / ORALRLD, RS2021-07-16a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N214783-001101839312033-10-07U-42602021-11-17a50c72e98297…
2026-08-01 22:54:322026-06N214783-001101839312033-10-07U-32462021-11-17a50c72e98297…
2026-08-01 22:54:322026-06N214783-001106966602033-10-07U-42602021-11-17a50c72e98297…
2026-08-01 22:54:322026-06N214783-001106966602033-10-07U-32462021-11-17a50c72e98297…
2026-08-01 22:54:322026-06N214783-00183576932034-06-20U-4259Drug substance, Drug product2021-11-17a50c72e98297…
2026-08-01 22:54:322026-06N214783-001113115412035-04-09U-33692022-05-25a50c72e98297…
2026-08-01 22:54:322026-06N214783-001120972022042-07-14U-40142024-10-24a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N214783-001NCE2026-07-16a50c72e98297…
2026-08-01 22:54:322026-06N214783-001ODE-3622028-07-16a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RezurockBELUMOSUDILKadmon Pharmaceuticals, LLC102e4ef4-7f84-4e34-8df1-479c24d1575d2026-04-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 214783
application number: NDA214783
ndc (product): 79802-200

Additional Listing Data#

Finished product
Yes
Brand name base
Rezurock
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BELUMOSUDIL200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
834YJF89WOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2564031Internal RxNorm lookup
2564037Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
102e4ef4-7f84-4e34-8df1-479c24d1575dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
248f3af0-50c4-4b45-b853-cbf867b4a88fProduct name120220126

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79802-200-30Rezurock30 in 1 BOTTLETABLET3011
79802-200-30Rezurock1 in 1 CARTONTABLET111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79802-200-30EA - Each79802-20075a6af71-6640-42af-b419-547af9e9bacc12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79802-200REZUROCK (BELUMOSUDIL) TABLET [KADMON PHARMACEUTICALS, LLC]9Current NDC, Legacy NDC, 2 package rows20250430_102e4ef4-7f84-4e34-8df1-479c24d1575d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2564031belumosudil 200 MG Oral TabletPSN102e4ef4-7f84-4e34-8df1-479c24d1575d11
2564037REZUROCK 200 MG Oral TabletPSN102e4ef4-7f84-4e34-8df1-479c24d1575d11
2564037belumosudil 200 MG Oral Tablet [Rezurock]SBD102e4ef4-7f84-4e34-8df1-479c24d1575d11
2564031belumosudil 200 MG Oral TabletSCD102e4ef4-7f84-4e34-8df1-479c24d1575d11
2564031belumosudil (as belumosudil mesylate) 200 MG Oral TabletSY102e4ef4-7f84-4e34-8df1-479c24d1575d11
2564037Rezurock 200 MG (as belumosudil mesylate 242.5 MG) Oral TabletSY102e4ef4-7f84-4e34-8df1-479c24d1575d11
2564037Rezurock 200 MG Oral TabletSY102e4ef4-7f84-4e34-8df1-479c24d1575d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79802-200-30798020200301 BOTTLE in 1 CARTON (79802-200-30) / 30 TABLET in 1 BOTTLE1 bottle2021-07-160000-00-00NoNoCurrent