TUKYSA
- Product NDC
- 51144-001
- 11-digit product format
- 511440001
- Labeler code
- 51144
- Product ID
- 51144-001_892c322b-be43-4180-89f7-4e3619a8b58f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tucatinib
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- SEAGEN INC.
- Application
- NDA213411
- Marketing category
- NDA
- Marketing start
- 2020-04-17
- Substance
- TUCATINIB
- Active strength
- 50 mg/1
- Pharmacologic classes
- Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], Tyrosine Kinase 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
- TUKYSA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TUCATINIB | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 234248D0HH |
| Rxcui | 2361290, 2361296, 2361298, 2361300 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51144-001-60 | TUKYSA | 60 in 1 BOTTLE | TABLET | 60 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51144-001 | TUKYSA (TUCATINIB) TABLET [SEAGEN INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20241105_f27eb1b9-b7fc-424e-988f-84dd7bb195a3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51144-001-60 | 51144000160 | 60 TABLET in 1 BOTTLE (51144-001-60) | 60 tablet | 2020-04-17 | 0000-00-00 | No | No | Current |