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

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 Identifiers#

Field, Values table
FieldValues
Unii834YJF89WO
Rxcui2564031, 2564037

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