Prescription drug · NDA
Romvimza (Vimseltinib) NDC 73207-303
Vimseltinib 20 mg/1 · Capsule · Oral · Deciphera Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73207-303-40 | 73207030340 | 1 CARTON in 1 CARTON (73207-303-40) / 1 BLISTER PACK in 1 CARTON / 8 CAPSULE in 1 BLISTER PACKMarketed from Feb 14, 2025 | |
| 73207-303-41 | 73207030341 | 1 CARTON in 1 CARTON (73207-303-41) / 1 BLISTER PACK in 1 CARTON / 4 CAPSULE in 1 BLISTER PACKMarketed from Feb 14, 2025 · Sample package |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Romvimza
- Generic name (nonproprietary)
- vimseltinib
- Active ingredients
- Vimseltinib — 20 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Deciphera Pharmaceuticals, LLCNDC labeler code 73207
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219304
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 73207-303_a1ac4da0-35e5-45c3-818b-4a76dbfb0279SPL ID a1ac4da0-35e5-45c3-818b-4a76dbfb0279SPL set ID f73c7a62-9601-4df0-810f-100f515d79eaRxCUI 2705406, 2705412, 2705414, 2705416, 2705418, 2705420UNII PX9FTM69BFUPC 0373207302407, 0373207304401, 0373207303404
- Pharmacologic class
- Kinase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N473207030340followed by a unit qualifier and the quantityPackage 73207-0303-40. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. ROMVIMZA is a kinase inhibitor indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 73207-303
- What is NDC 73207-303?
- 73207-303 is the product NDC for Romvimza (vimseltinib), Vimseltinib 20 mg/1 capsule, listed with the FDA by Deciphera Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Romvimza (Vimseltinib).
- What is the active ingredient?
- Vimseltinib.
- Who is the labeler?
- Deciphera Pharmaceuticals, LLC, NDC labeler code 73207. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Romvimza?
- 2 other product NDCs are listed under this name. See all Romvimza NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Romvimza products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Romvimzavimseltinib | Vimseltinib 14 mg/1 | CapsuleOral | Deciphera Pharmaceuticals, LLC | 73207-302 | 73207-0302-4073207-0302-41 |
| Romvimzavimseltinib | Vimseltinib 30 mg/1 | CapsuleOral | Deciphera Pharmaceuticals, LLC | 73207-304 | 73207-0304-4073207-0304-41 |
Other NDCs under NDA 219304
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Romvimzavimseltinib | Vimseltinib 14 mg/1 | CapsuleOral | Deciphera Pharmaceuticals, LLC | 73207-302 |
| Romvimzavimseltinib | Vimseltinib 30 mg/1 | CapsuleOral | Deciphera Pharmaceuticals, LLC | 73207-304 |