KOSELUGO
- Product NDC
- 0310-0640
- 11-digit product format
- 003100640
- Labeler code
- 0310
- Product ID
- 0310-0640_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
- 7.5 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 6UH91I579U | SELUMETINIB | 606143-52-6 | SELUMETINIB |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0310-0640-60 | 00310064060 | 60 GRANULE in 1 BOTTLE (0310-0640-60) | 60 granule | 2025-09-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| KOSELUGO | AstraZeneca Pharmaceuticals LP | 2025-11-19 | HUMAN PRESCRIPTION DRUG LABEL | 16 |
| KOSELUGO | AstraZeneca Pharmaceuticals LP | AstraZeneca PLC | 2025-09-10 | HUMAN PRESCRIPTION DRUG LABEL | 11 |