ROMVIMZA
- Product NDC
- 73207-302
- 11-digit product format
- 732070302
- Labeler code
- 73207
- Product ID
- 73207-302_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
- 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
- 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| Ingredient | Strength |
|---|
| VIMSELTINIB | 14 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | PX9FTM69BF |
| Rxcui | 2705406, 2705412, 2705414, 2705416, 2705418, 2705420 |
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 |
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 |