Home NDC 73207-302 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219304-001 ROMVIMZA VIMSELTINIB 14MG CAPSULE / ORAL RLD 2025-02-14 N219304-002 ROMVIMZA VIMSELTINIB 20MG CAPSULE / ORAL RLD 2025-02-14 N219304-003 ROMVIMZA VIMSELTINIB 30MG CAPSULE / ORAL RLD, RS 2025-02-14
Orange Book patents# Current patent rows page 1 of 1 · 39 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219304-001 9181223 2034-03-14 Drug substance, Drug product 2025-03-05 N219304-001 12285430 2039-12-23 U-4145 2025-05-02 N219304-001 12485120 2039-12-23 U-4145 2025-12-10 N219304-001 12582655 2039-12-23 U-4145 2026-04-06 N219304-001 11103507 2040-02-03 U-4145 2025-03-05 N219304-001 11679110 2040-02-03 U-4145 2025-03-05 N219304-001 12447149 2044-12-06 Drug product 2025-10-24 N219304-001 12528787 2044-12-06 Drug substance, Drug product 2026-02-02 N219304-001 12551483 2044-12-06 Drug product 2026-02-23 N219304-001 12617775 2044-12-06 Drug substance, Drug product 2026-05-20 N219304-001 12643883 2044-12-06 Drug substance, Drug product 2026-06-08 N219304-001 12509443 2045-04-30 Drug product 2026-01-14 N219304-001 12686672 2045-04-30 Drug product 2026-07-28 N219304-002 9181223 2034-03-14 Drug substance, Drug product 2025-03-05 N219304-002 12285430 2039-12-23 U-4145 2025-05-02 N219304-002 12485120 2039-12-23 U-4145 2025-12-10 N219304-002 12582655 2039-12-23 U-4145 2026-04-06 N219304-002 11103507 2040-02-03 U-4145 2025-03-05 N219304-002 11679110 2040-02-03 U-4145 2025-03-05 N219304-002 12447149 2044-12-06 Drug product 2025-10-24 N219304-002 12528787 2044-12-06 Drug substance, Drug product 2026-02-02 N219304-002 12551483 2044-12-06 Drug product 2026-02-23 N219304-002 12617775 2044-12-06 Drug substance, Drug product 2026-05-20 N219304-002 12643883 2044-12-06 Drug substance, Drug product 2026-06-08 N219304-002 12509443 2045-04-30 Drug product 2026-01-14 N219304-002 12686672 2045-04-30 Drug product 2026-07-28 N219304-003 9181223 2034-03-14 Drug substance, Drug product 2025-03-05 N219304-003 12285430 2039-12-23 U-4145 2025-05-02 N219304-003 12485120 2039-12-23 U-4145 2025-12-10 N219304-003 12582655 2039-12-23 U-4145 2026-04-06 N219304-003 11103507 2040-02-03 U-4145 2025-03-05 N219304-003 11679110 2040-02-03 U-4145 2025-03-05 N219304-003 12447149 2044-12-06 Drug product 2025-10-24 N219304-003 12528787 2044-12-06 Drug substance, Drug product 2026-02-02 N219304-003 12551483 2044-12-06 Drug product 2026-02-23 N219304-003 12617775 2044-12-06 Drug substance, Drug product 2026-05-20 N219304-003 12643883 2044-12-06 Drug substance, Drug product 2026-06-08 N219304-003 12509443 2045-04-30 Drug product 2026-01-14 N219304-003 12686672 2045-04-30 Drug product 2026-07-28
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N219304-001 NCE 2030-02-14 N219304-002 NCE 2030-02-14 N219304-003 NCE 2030-02-14
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 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 N219304-001 ROMVIMZA 14MG CAPSULE / ORAL RLD 2025-02-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-002 ROMVIMZA 20MG CAPSULE / ORAL RLD 2025-02-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-003 ROMVIMZA 30MG CAPSULE / ORAL RLD, RS 2025-02-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219304-001 ROMVIMZA 14MG CAPSULE / ORAL RLD 2025-02-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219304-002 ROMVIMZA 20MG CAPSULE / ORAL RLD 2025-02-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219304-003 ROMVIMZA 30MG CAPSULE / ORAL RLD, RS 2025-02-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219304-001 ROMVIMZA 14MG CAPSULE / ORAL RLD 2025-02-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219304-002 ROMVIMZA 20MG CAPSULE / ORAL RLD 2025-02-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219304-003 ROMVIMZA 30MG CAPSULE / ORAL RLD, RS 2025-02-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219304-001 ROMVIMZA 14MG CAPSULE / ORAL RLD 2025-02-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219304-002 ROMVIMZA 20MG CAPSULE / ORAL RLD 2025-02-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219304-003 ROMVIMZA 30MG CAPSULE / ORAL RLD, RS 2025-02-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219304-001 ROMVIMZA 14MG CAPSULE / ORAL RLD 2025-02-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219304-002 ROMVIMZA 20MG CAPSULE / ORAL RLD 2025-02-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219304-003 ROMVIMZA 30MG CAPSULE / ORAL RLD, RS 2025-02-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219304-001 ROMVIMZA 14MG CAPSULE / ORAL RLD 2025-02-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219304-002 ROMVIMZA 20MG CAPSULE / ORAL RLD 2025-02-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219304-003 ROMVIMZA 30MG CAPSULE / ORAL RLD, RS 2025-02-14 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219304-001 ROMVIMZA 14MG CAPSULE / ORAL RLD 2025-02-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219304-002 ROMVIMZA 20MG CAPSULE / ORAL RLD 2025-02-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219304-003 ROMVIMZA 30MG CAPSULE / ORAL RLD, RS 2025-02-14 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 177 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 N219304-001 9181223 2034-03-14 Drug substance, Drug product 2025-03-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-001 12285430 2039-12-23 U-4145 2025-05-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-001 12485120 2039-12-23 U-4145 2025-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-001 12582655 2039-12-23 U-4145 2026-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-001 11103507 2040-02-03 U-4145 2025-03-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-001 11679110 2040-02-03 U-4145 2025-03-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-001 12447149 2044-12-06 Drug product 2025-10-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-001 12528787 2044-12-06 Drug substance, Drug product 2026-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-001 12551483 2044-12-06 Drug product 2026-02-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-001 12617775 2044-12-06 Drug substance, Drug product 2026-05-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-001 12643883 2044-12-06 Drug substance, Drug product 2026-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-001 12509443 2045-04-30 Drug product 2026-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-001 12686672 2045-04-30 Drug product 2026-07-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-002 9181223 2034-03-14 Drug substance, Drug product 2025-03-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-002 12285430 2039-12-23 U-4145 2025-05-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-002 12485120 2039-12-23 U-4145 2025-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-002 12582655 2039-12-23 U-4145 2026-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-002 11103507 2040-02-03 U-4145 2025-03-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-002 11679110 2040-02-03 U-4145 2025-03-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-002 12447149 2044-12-06 Drug product 2025-10-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-002 12528787 2044-12-06 Drug substance, Drug product 2026-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-002 12551483 2044-12-06 Drug product 2026-02-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-002 12617775 2044-12-06 Drug substance, Drug product 2026-05-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-002 12643883 2044-12-06 Drug substance, Drug product 2026-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-002 12509443 2045-04-30 Drug product 2026-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-002 12686672 2045-04-30 Drug product 2026-07-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-003 9181223 2034-03-14 Drug substance, Drug product 2025-03-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-003 12285430 2039-12-23 U-4145 2025-05-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-003 12485120 2039-12-23 U-4145 2025-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-003 12582655 2039-12-23 U-4145 2026-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-003 11103507 2040-02-03 U-4145 2025-03-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-003 11679110 2040-02-03 U-4145 2025-03-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-003 12447149 2044-12-06 Drug product 2025-10-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-003 12528787 2044-12-06 Drug substance, Drug product 2026-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-003 12551483 2044-12-06 Drug product 2026-02-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-003 12617775 2044-12-06 Drug substance, Drug product 2026-05-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-003 12643883 2044-12-06 Drug substance, Drug product 2026-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-003 12509443 2045-04-30 Drug product 2026-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219304-003 12686672 2045-04-30 Drug product 2026-07-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219304-001 9181223 2034-03-14 Drug substance, Drug product 2025-03-05 caaa826d4ba7…
Observed Orange Book exclusivity history# 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 Ingredient Strength VIMSELTINIB 14 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PX9FTM69BF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2705406 Internal RxNorm lookup 2705412 Internal RxNorm lookup 2705414 Internal RxNorm lookup 2705416 Internal RxNorm lookup 2705418 Internal RxNorm lookup 2705420 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 73207-302-40 ROMVIMZA 1 in 1 CARTON CAPSULE 1 2 73207-302-41 ROMVIMZA 1 in 1 CARTON CAPSULE 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73207-302 ROMVIMZA (VIMSELTINIB) CAPSULE [DECIPHERA PHARMACEUTICALS, LLC] 1 Current NDC, 2 package rows 20250221_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 73207-302-40 73207030240 1 CARTON in 1 CARTON (73207-302-40) / 1 BLISTER PACK in 1 CARTON / 8 CAPSULE in 1 BLISTER PACK 1 carton 2025-02-14 No No Current 73207-302-41 73207030241 1 CARTON in 1 CARTON (73207-302-41) / 1 BLISTER PACK in 1 CARTON / 4 CAPSULE in 1 BLISTER PACK 1 carton 2025-02-14 Yes No Current