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NDC 00310-0625-28 KOSELUGO 25 mg/1 Details
KOSELUGO 25 mg/1
KOSELUGO is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AstraZeneca Pharmaceuticals LP. The primary component is SELUMETINIB.
MedlinePlus Drug Summary
Selumetinib is used to treat neurofibromatosis type 1 (NF1; a nervous system disorder that causes tumors to grow on nerves) in children 2 years of age and older who have plexiform neurofibromas (PN; soft tumors) that cannot be completely removed by surgery. Selumetinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals the tumors to grow. This helps to stop or slow tumor growth.
Related Packages: 00310-0625-28Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Selumetinib
Product Information
| NDC | 00310-0625 |
|---|---|
| Product ID | 0310-0625_6c8f682f-896f-4f33-9edc-97c152c1f452 |
| Associated GPIs | 21533565500125 |
| GCN Sequence Number | 080922 |
| GCN Sequence Number Description | selumetinib/vitamin E TPGS CAPSULE 25 MG ORAL |
| HIC3 | V3U |
| HIC3 Description | ANTINEOPLASTIC - MEK1 AND MEK2 KINASE INHIBITORS |
| GCN | 47909 |
| HICL Sequence Number | 046451 |
| HICL Sequence Number Description | SELUMETINIB SULFATE/VITAMIN E TPGS |
| Brand/Generic | Brand |
| Proprietary Name | KOSELUGO |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | SELUMETINIB |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/1 |
| Substance Name | SELUMETINIB |
| Labeler Name | AstraZeneca Pharmaceuticals LP |
| Pharmaceutical Class | Kinase Inhibitor [EPC], Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA], Mitogen-Activated Protein Kinase Kinase 2 Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA213756 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00310-0625-28 (00310062528)
| NDC Package Code | 0310-0625-28 |
|---|---|
| Billing NDC | 00310062528 |
| Package | 28 CAPSULE in 1 BOTTLE (0310-0625-28) |
| Marketing Start Date | 2021-06-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |