ROMVIMZA Capsule Ref.[115532] Active ingredients: Vimseltinib

Source: FDA, National Drug Code (US) Revision Year: 2025

Product description

Vimseltinib is a kinase inhibitor. The chemical name of vimseltinib dihydrate is 3-methyl-5-[6-methyl-5-[2-(1-methylpyrazol-4-yl)pyridin-4-yl]oxypyridin-2-yl]-2-(propan-2-ylamino)pyrimidin-4-one, dihydrate.

Vimseltinib is a white to off-white crystalline solid. Vimseltinib is a weak base, very slightly soluble in water. The molecular formula for vimseltinib dihydrate is C₂₃H₂₅N₇O₂ • 2H₂O, and the molecular weight is 467.52 g/mol.

The chemical structure is:

ROMVIMZA (vimseltinib) capsules are supplied as printed hard gelatin capsules containing 14 mg, 20 mg, or 30 mg of vimseltinib (equivalent to 15.18 mg, 21.68 mg, or 32.52 mg of vimseltinib dihydrate, respectively). The capsule contains the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shell contains Brilliant Blue FCF (30 mg strength), erythrosine (30 mg strength), gelatin, Sunset Yellow FCF (14 mg and 20 mg strengths), tartrazine (20 mg), and titanium dioxide.

Dosage Forms and Strengths
14 mg capsule: Orange cap, white body size 4 capsule imprinted with "DCV14" in black ink. 20 mg capsule: Yellow cap, white body size 2 capsule imprinted with "DCV20" in black ink. 30 mg capsule: Light blue cap, white body size 1 capsule imprinted with "DCV30" in black ink.

How Supplied

Table 7. ROMVIMZA 14 mg, 20 mg, and 30 mg Capsules:

Strength	Description	Package Size and Type	NDC Number
14 mg	Size 4 hard gelatin capsule with white body and orange cap with black print "DCV14", packed in oPA-film/aluminum foil/PVC-film blisters with push-through aluminum foil lidding.	Each carton contains one child-resistant blister pack containing 8 capsules (four-week supply)	73207-302-40
20 mg	Size 2 hard gelatin capsule with white body and yellow cap with black print "DCV20", packed in oPA-film/aluminum foil/PVC-film blisters with push-through aluminum foil lidding.	Each carton contains one child-resistant blister pack containing 8 capsules (four-week supply)	73207-303-40
30 mg	Size 1 hard gelatin capsule with white body and light blue cap with black print "DCV30", packed in oPA-film/aluminum foil/PVC-film blisters with push- through aluminum foil lidding.	Each carton contains one child-resistant blister pack containing 8 capsules (four-week supply)	73207-304-40

Manufactured for and marketed by: Deciphera Pharmaceuticals, LLC, 200 Smith Street, Waltham, MA 02451

Drugs

Drug	Countries
ROMVIMZA	United States

Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.