Prescription drug · NDA
Tukysa (tucatinib) NDC 51144-001
Tucatinib 50 mg/1 · Tablet · Oral · SEAGEN INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51144-001-60 | 51144000160 | 60 TABLET in 1 BOTTLE (51144-001-60)Marketed from Apr 17, 2020 |
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)
- Tukysa
- Generic name (nonproprietary)
- tucatinib
- Active ingredients
- Tucatinib — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- SEAGEN INC.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213411
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Tyrosine Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 51144-001_892c322b-be43-4180-89f7-4e3619a8b58fSPL ID 892c322b-be43-4180-89f7-4e3619a8b58fSPL set ID f27eb1b9-b7fc-424e-988f-84dd7bb195a3RxCUI 2361290, 2361296, 2361298, 2361300UNII 234248D0HH
- 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
N451144000160followed by a unit qualifier and the quantityPackage 51144-0001-60. 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)
TUKYSA is a kinase inhibitor indicated: • in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. ( 1.1 ) • in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. ( 1.2 ) This indication is approved under accelerated approval based on tumor response rate and durability o…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 213411
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 |
|---|---|---|---|---|
| Tukysatucatinib | Tucatinib 150 mg/1 | TabletOral | SEAGEN INC. | 51144-002 |