ROMVIMZA

Product NDC
73207-302
11-digit product format
732070302
Labeler code
73207
Product ID
73207-302_a1ac4da0-35e5-45c3-818b-4a76dbfb0279
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
14 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
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219304-001ROMVIMZAVIMSELTINIB14MGCAPSULE / ORALRLD2025-02-14
N219304-002ROMVIMZAVIMSELTINIB20MGCAPSULE / ORALRLD2025-02-14
N219304-003ROMVIMZAVIMSELTINIB30MGCAPSULE / ORALRLD, RS2025-02-14

Orange Book patents#

Current patent rows page 1 of 1 · 39 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219304-00191812232034-03-14Drug substance, Drug product2025-03-05
N219304-001122854302039-12-23U-41452025-05-02
N219304-001124851202039-12-23U-41452025-12-10
N219304-001125826552039-12-23U-41452026-04-06
N219304-001111035072040-02-03U-41452025-03-05
N219304-001116791102040-02-03U-41452025-03-05
N219304-001124471492044-12-06Drug product2025-10-24
N219304-001125287872044-12-06Drug substance, Drug product2026-02-02
N219304-001125514832044-12-06Drug product2026-02-23
N219304-001126177752044-12-06Drug substance, Drug product2026-05-20
N219304-001126438832044-12-06Drug substance, Drug product2026-06-08
N219304-001125094432045-04-30Drug product2026-01-14
N219304-001126866722045-04-30Drug product2026-07-28
N219304-00291812232034-03-14Drug substance, Drug product2025-03-05
N219304-002122854302039-12-23U-41452025-05-02
N219304-002124851202039-12-23U-41452025-12-10
N219304-002125826552039-12-23U-41452026-04-06
N219304-002111035072040-02-03U-41452025-03-05
N219304-002116791102040-02-03U-41452025-03-05
N219304-002124471492044-12-06Drug product2025-10-24
N219304-002125287872044-12-06Drug substance, Drug product2026-02-02
N219304-002125514832044-12-06Drug product2026-02-23
N219304-002126177752044-12-06Drug substance, Drug product2026-05-20
N219304-002126438832044-12-06Drug substance, Drug product2026-06-08
N219304-002125094432045-04-30Drug product2026-01-14
N219304-002126866722045-04-30Drug product2026-07-28
N219304-00391812232034-03-14Drug substance, Drug product2025-03-05
N219304-003122854302039-12-23U-41452025-05-02
N219304-003124851202039-12-23U-41452025-12-10
N219304-003125826552039-12-23U-41452026-04-06
N219304-003111035072040-02-03U-41452025-03-05
N219304-003116791102040-02-03U-41452025-03-05
N219304-003124471492044-12-06Drug product2025-10-24
N219304-003125287872044-12-06Drug substance, Drug product2026-02-02
N219304-003125514832044-12-06Drug product2026-02-23
N219304-003126177752044-12-06Drug substance, Drug product2026-05-20
N219304-003126438832044-12-06Drug substance, Drug product2026-06-08
N219304-003125094432045-04-30Drug product2026-01-14
N219304-003126866722045-04-30Drug product2026-07-28

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219304-001NCE2030-02-14
N219304-002NCE2030-02-14
N219304-003NCE2030-02-14

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
2026-09-14 22:38:342026-08N219304-001ROMVIMZA14MGCAPSULE / ORALRLD2025-02-1484e616aacf4f…
2026-09-14 22:38:342026-08N219304-002ROMVIMZA20MGCAPSULE / ORALRLD2025-02-1484e616aacf4f…
2026-09-14 22:38:342026-08N219304-003ROMVIMZA30MGCAPSULE / ORALRLD, RS2025-02-1484e616aacf4f…
2026-08-18 06:07:402026-07N219304-001ROMVIMZA14MGCAPSULE / ORALRLD2025-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07N219304-002ROMVIMZA20MGCAPSULE / ORALRLD2025-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07N219304-003ROMVIMZA30MGCAPSULE / ORALRLD, RS2025-02-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219304-001ROMVIMZA14MGCAPSULE / ORALRLD2025-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219304-002ROMVIMZA20MGCAPSULE / ORALRLD2025-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219304-003ROMVIMZA30MGCAPSULE / ORALRLD, RS2025-02-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219304-001ROMVIMZA14MGCAPSULE / ORALRLD2025-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219304-002ROMVIMZA20MGCAPSULE / ORALRLD2025-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219304-003ROMVIMZA30MGCAPSULE / ORALRLD, RS2025-02-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N219304-001ROMVIMZA14MGCAPSULE / ORALRLD2025-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219304-002ROMVIMZA20MGCAPSULE / ORALRLD2025-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219304-003ROMVIMZA30MGCAPSULE / ORALRLD, RS2025-02-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219304-001ROMVIMZA14MGCAPSULE / ORALRLD2025-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219304-002ROMVIMZA20MGCAPSULE / ORALRLD2025-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219304-003ROMVIMZA30MGCAPSULE / ORALRLD, RS2025-02-14fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219304-001ROMVIMZA14MGCAPSULE / ORALRLD2025-02-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219304-002ROMVIMZA20MGCAPSULE / ORALRLD2025-02-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219304-003ROMVIMZA30MGCAPSULE / ORALRLD, RS2025-02-14a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 5 · 177 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N219304-00191812232034-03-14Drug substance, Drug product2025-03-0584e616aacf4f…
2026-09-14 22:38:342026-08N219304-001122854302039-12-23U-41452025-05-0284e616aacf4f…
2026-09-14 22:38:342026-08N219304-001124851202039-12-23U-41452025-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N219304-001125826552039-12-23U-41452026-04-0684e616aacf4f…
2026-09-14 22:38:342026-08N219304-001111035072040-02-03U-41452025-03-0584e616aacf4f…
2026-09-14 22:38:342026-08N219304-001116791102040-02-03U-41452025-03-0584e616aacf4f…
2026-09-14 22:38:342026-08N219304-001124471492044-12-06Drug product2025-10-2484e616aacf4f…
2026-09-14 22:38:342026-08N219304-001125287872044-12-06Drug substance, Drug product2026-02-0284e616aacf4f…
2026-09-14 22:38:342026-08N219304-001125514832044-12-06Drug product2026-02-2384e616aacf4f…
2026-09-14 22:38:342026-08N219304-001126177752044-12-06Drug substance, Drug product2026-05-2084e616aacf4f…
2026-09-14 22:38:342026-08N219304-001126438832044-12-06Drug substance, Drug product2026-06-0884e616aacf4f…
2026-09-14 22:38:342026-08N219304-001125094432045-04-30Drug product2026-01-1484e616aacf4f…
2026-09-14 22:38:342026-08N219304-001126866722045-04-30Drug product2026-07-2884e616aacf4f…
2026-09-14 22:38:342026-08N219304-00291812232034-03-14Drug substance, Drug product2025-03-0584e616aacf4f…
2026-09-14 22:38:342026-08N219304-002122854302039-12-23U-41452025-05-0284e616aacf4f…
2026-09-14 22:38:342026-08N219304-002124851202039-12-23U-41452025-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N219304-002125826552039-12-23U-41452026-04-0684e616aacf4f…
2026-09-14 22:38:342026-08N219304-002111035072040-02-03U-41452025-03-0584e616aacf4f…
2026-09-14 22:38:342026-08N219304-002116791102040-02-03U-41452025-03-0584e616aacf4f…
2026-09-14 22:38:342026-08N219304-002124471492044-12-06Drug product2025-10-2484e616aacf4f…
2026-09-14 22:38:342026-08N219304-002125287872044-12-06Drug substance, Drug product2026-02-0284e616aacf4f…
2026-09-14 22:38:342026-08N219304-002125514832044-12-06Drug product2026-02-2384e616aacf4f…
2026-09-14 22:38:342026-08N219304-002126177752044-12-06Drug substance, Drug product2026-05-2084e616aacf4f…
2026-09-14 22:38:342026-08N219304-002126438832044-12-06Drug substance, Drug product2026-06-0884e616aacf4f…
2026-09-14 22:38:342026-08N219304-002125094432045-04-30Drug product2026-01-1484e616aacf4f…
2026-09-14 22:38:342026-08N219304-002126866722045-04-30Drug product2026-07-2884e616aacf4f…
2026-09-14 22:38:342026-08N219304-00391812232034-03-14Drug substance, Drug product2025-03-0584e616aacf4f…
2026-09-14 22:38:342026-08N219304-003122854302039-12-23U-41452025-05-0284e616aacf4f…
2026-09-14 22:38:342026-08N219304-003124851202039-12-23U-41452025-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N219304-003125826552039-12-23U-41452026-04-0684e616aacf4f…
2026-09-14 22:38:342026-08N219304-003111035072040-02-03U-41452025-03-0584e616aacf4f…
2026-09-14 22:38:342026-08N219304-003116791102040-02-03U-41452025-03-0584e616aacf4f…
2026-09-14 22:38:342026-08N219304-003124471492044-12-06Drug product2025-10-2484e616aacf4f…
2026-09-14 22:38:342026-08N219304-003125287872044-12-06Drug substance, Drug product2026-02-0284e616aacf4f…
2026-09-14 22:38:342026-08N219304-003125514832044-12-06Drug product2026-02-2384e616aacf4f…
2026-09-14 22:38:342026-08N219304-003126177752044-12-06Drug substance, Drug product2026-05-2084e616aacf4f…
2026-09-14 22:38:342026-08N219304-003126438832044-12-06Drug substance, Drug product2026-06-0884e616aacf4f…
2026-09-14 22:38:342026-08N219304-003125094432045-04-30Drug product2026-01-1484e616aacf4f…
2026-09-14 22:38:342026-08N219304-003126866722045-04-30Drug product2026-07-2884e616aacf4f…
2026-08-18 06:07:402026-07N219304-00191812232034-03-14Drug substance, Drug product2025-03-05caaa826d4ba7…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N219304-001NCE2030-02-1484e616aacf4f…
2026-09-14 22:38:342026-08N219304-002NCE2030-02-1484e616aacf4f…
2026-09-14 22:38:342026-08N219304-003NCE2030-02-1484e616aacf4f…
2026-08-18 06:07:402026-07N219304-001NCE2030-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07N219304-002NCE2030-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07N219304-003NCE2030-02-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219304-001NCE2030-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219304-002NCE2030-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219304-003NCE2030-02-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219304-001NCE2030-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219304-002NCE2030-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219304-003NCE2030-02-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N219304-001NCE2030-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219304-002NCE2030-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219304-003NCE2030-02-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219304-001NCE2030-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219304-002NCE2030-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219304-003NCE2030-02-14fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219304-001NCE2030-02-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219304-002NCE2030-02-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219304-003NCE2030-02-14a50c72e98297…

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
ROMVIMZA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VIMSELTINIB14 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PX9FTM69BFInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2705406Internal RxNorm lookup
2705412Internal RxNorm lookup
2705414Internal RxNorm lookup
2705416Internal RxNorm lookup
2705418Internal RxNorm lookup
2705420Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f73c7a62-9601-4df0-810f-100f515d79eaAvailable on FDA.report

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
73207-302-40ROMVIMZA1 in 1 CARTONCAPSULE12
73207-302-41ROMVIMZA1 in 1 CARTONCAPSULE12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73207-302-40EA - Each73207-3022fad7fa3-1a61-41ce-b916-1060bef8cbb412025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73207-302ROMVIMZA (VIMSELTINIB) CAPSULE [DECIPHERA PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20250221_f73c7a62-9601-4df0-810f-100f515d79ea.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ROMVIMZAVIMSELTINIBDeciphera Pharmaceuticals, LLCf73c7a62-9601-4df0-810f-100f515d79ea2026-06-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 219304
application number: NDA219304
ndc (product): 73207-302

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
73207-302-40732070302401 CARTON in 1 CARTON (73207-302-40) / 1 BLISTER PACK in 1 CARTON / 8 CAPSULE in 1 BLISTER PACK1 carton2025-02-14NoNoCurrent
73207-302-41732070302411 CARTON in 1 CARTON (73207-302-41) / 1 BLISTER PACK in 1 CARTON / 4 CAPSULE in 1 BLISTER PACK1 carton2025-02-14YesNoCurrent