FDA.reportPublic FDA data

ROMVIMZA

Product NDC
73207-304
11-digit product format
732070304
Labeler code
73207
Product ID
73207-304_6362e653-0e8c-4b90-b4e9-89647080e9d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vimseltinib
Dosage form
CAPSULE
Route
ORAL
Labeler
Deciphera Pharmaceuticals, LLC
Application
NDA219304
Marketing category
NDA
Marketing start
2025-02-14
Substance
VIMSELTINIB
Active strength
30 mg/1
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors [MoA], Kinase Inhibitor [EPC], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VIMSELTINIB30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPX9FTM69BF
Rxcui2705406, 2705412, 2705414, 2705416, 2705418, 2705420

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fdae9bbe-100f-4f7c-b5da-b32777a9f778Product name120251121

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73207-304-40ROMVIMZA1 in 1 CARTONCAPSULE12
73207-304-41ROMVIMZA1 in 1 CARTONCAPSULE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73207-304ROMVIMZA (VIMSELTINIB) CAPSULE [DECIPHERA PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20250221_f73c7a62-9601-4df0-810f-100f515d79ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2705412Romvimza 14 MG Oral CapsulePSNf73c7a62-9601-4df0-810f-100f515d79ea2
2705416Romvimza 20 MG Oral CapsulePSNf73c7a62-9601-4df0-810f-100f515d79ea2
2705420Romvimza 30 MG Oral CapsulePSNf73c7a62-9601-4df0-810f-100f515d79ea2
2705406vimseltinib 14 MG Oral CapsulePSNf73c7a62-9601-4df0-810f-100f515d79ea2
2705414vimseltinib 20 MG Oral CapsulePSNf73c7a62-9601-4df0-810f-100f515d79ea2
2705418vimseltinib 30 MG Oral CapsulePSNf73c7a62-9601-4df0-810f-100f515d79ea2
2705412vimseltinib 14 MG Oral Capsule [Romvimza]SBDf73c7a62-9601-4df0-810f-100f515d79ea2
2705416vimseltinib 20 MG Oral Capsule [Romvimza]SBDf73c7a62-9601-4df0-810f-100f515d79ea2
2705420vimseltinib 30 MG Oral Capsule [Romvimza]SBDf73c7a62-9601-4df0-810f-100f515d79ea2
2705406vimseltinib 14 MG Oral CapsuleSCDf73c7a62-9601-4df0-810f-100f515d79ea2
2705414vimseltinib 20 MG Oral CapsuleSCDf73c7a62-9601-4df0-810f-100f515d79ea2
2705418vimseltinib 30 MG Oral CapsuleSCDf73c7a62-9601-4df0-810f-100f515d79ea2
2705412Romvimza 14 MG Oral CapsuleSYf73c7a62-9601-4df0-810f-100f515d79ea2
2705416Romvimza 20 MG Oral CapsuleSYf73c7a62-9601-4df0-810f-100f515d79ea2
2705420Romvimza 30 MG Oral CapsuleSYf73c7a62-9601-4df0-810f-100f515d79ea2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73207-304-40732070304401 CARTON in 1 CARTON (73207-304-40) / 1 BLISTER PACK in 1 CARTON / 8 CAPSULE in 1 BLISTER PACK1 carton2025-02-14NoNoCurrent
73207-304-41732070304411 CARTON in 1 CARTON (73207-304-41) / 1 BLISTER PACK in 1 CARTON / 4 CAPSULE in 1 BLISTER PACK1 carton2025-02-14YesNoCurrent