KOSELUGO
- Product NDC
- 0310-0635
- 11-digit product format
- 003100635
- Labeler code
- 0310
- Product ID
- 0310-0635_b3809b9c-c5d0-44c6-9c21-abcc230f64ac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SELUMETINIB
- Dosage form
- GRANULE
- Route
- ORAL
- Labeler
- AstraZeneca Pharmaceuticals LP
- Application
- NDA219943
- Marketing category
- NDA
- Marketing start
- 2025-09-10
- Substance
- SELUMETINIB
- Active strength
- 5 mg/1
- Pharmacologic classes
- Kinase Inhibitor [EPC], Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA], Mitogen-Activated Protein Kinase Kinase 2 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
- KOSELUGO
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SELUMETINIB | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6UH91I579U |
| Rxcui | 2289418, 2289424, 2289426, 2289428, 2723653, 2723657, 2723659, 2723661 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0310-0635-60 | KOSELUGO | 60 in 1 BOTTLE | GRANULE | 60 | | 16 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0310-0635-60 | 00310063560 | 60 GRANULE in 1 BOTTLE (0310-0635-60) | 60 granule | 2025-09-10 | No | No | Current |