Package 0310-0635-60

Brand: koselugo

Generic: selumetinib
NDC Package

Package Facts

Identity

Package NDC 0310-0635-60
Digits Only 0310063560
Product NDC 0310-0635
Product ID 0310-0635_b3809b9c-c5d0-44c6-9c21-abcc230f64ac
Description

60 GRANULE in 1 BOTTLE (0310-0635-60)

Marketing

Marketing Status
Marketed Since 2025-09-10
Brand koselugo
Generic selumetinib
Sample Package No

Linked Drug Pages (1)

KOSELUGO ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b3809b9c-c5d0-44c6-9c21-abcc230f64ac", "openfda": {"nui": ["N0000175605", "N0000193943", "N0000193944"], "unii": ["6UH91I579U"], "rxcui": ["2289418", "2289424", "2289426", "2289428", "2723653", "2723657", "2723659", "2723661"], "spl_set_id": ["7d042c61-f28f-4ab5-ab10-d7558c0d49ff"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA]", "Mitogen-Activated Protein Kinase Kinase 2 Inhibitors [MoA]"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 GRANULE in 1 BOTTLE (0310-0635-60)", "package_ndc": "0310-0635-60", "marketing_start_date": "20250910"}], "brand_name": "KOSELUGO", "product_id": "0310-0635_b3809b9c-c5d0-44c6-9c21-abcc230f64ac", "dosage_form": "GRANULE", "pharm_class": ["Kinase Inhibitor [EPC]", "Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA]", "Mitogen-Activated Protein Kinase Kinase 2 Inhibitors [MoA]"], "product_ndc": "0310-0635", "generic_name": "SELUMETINIB", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KOSELUGO", "active_ingredients": [{"name": "SELUMETINIB", "strength": "5 mg/1"}], "application_number": "NDA219943", "marketing_category": "NDA", "marketing_start_date": "20250910", "listing_expiration_date": "20261231"}