SUTENT
- Product NDC
- 63539-019
- 11-digit product format
- 635390019
- Labeler code
- 63539
- Product ID
- 63539-019_21cadbc0-3f0e-4789-80ee-bf1e3982d85f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sunitinib malate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- U.S. Pharmaceuticals
- Application
- NDA021938
- Marketing category
- NDA
- Marketing start
- 2006-01-26
- Substance
- SUNITINIB MALATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 |
|---|
| 63539-019-01 | SUTENT | 14 in 1 BOTTLE | CAPSULE | 14 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63539-019 | SUTENT (SUNITINIB MALATE) CAPSULE [U.S. PHARMACEUTICALS] | 5 | Current NDC, Legacy NDC, 1 package rows | 20250325_a5d555f5-d66a-4f94-abcf-96fa6d71a32f.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63539-019-01 | 63539001901 | 14 CAPSULE in 1 BOTTLE (63539-019-01) | 14 capsule | 2017-05-02 | 0000-00-00 | Yes | No | Current |