Package 81927-201-01

Brand: imkeldi

Generic: imatinib oral
NDC Package

Package Facts

Identity

Package NDC 81927-201-01
Digits Only 8192720101
Product NDC 81927-201
Product ID 81927-201_dead98c8-2ac0-4fe6-890a-cc8c92ddcffc
Description

140 mL in 1 BOTTLE (81927-201-01)

Marketing

Marketing Status
Marketed Since 2024-12-19
Brand imkeldi
Generic imatinib oral
Sample Package No

Linked Drug Pages (1)

IMKELDI ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "dead98c8-2ac0-4fe6-890a-cc8c92ddcffc", "openfda": {"unii": ["8A1O1M485B"], "rxcui": ["2699831", "2699837"], "spl_set_id": ["26658bb7-9ba1-a10e-e063-6394a90a172e"], "manufacturer_name": ["Shorla Oncology Inc.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "140 mL in 1 BOTTLE (81927-201-01)", "package_ndc": "81927-201-01", "marketing_start_date": "20241219"}], "brand_name": "IMKELDI", "product_id": "81927-201_dead98c8-2ac0-4fe6-890a-cc8c92ddcffc", "dosage_form": "SOLUTION", "pharm_class": ["Bcr-Abl Tyrosine Kinase Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Kinase Inhibitor [EPC]"], "product_ndc": "81927-201", "generic_name": "imatinib oral", "labeler_name": "Shorla Oncology Inc.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IMKELDI", "active_ingredients": [{"name": "IMATINIB MESYLATE", "strength": "80 mg/mL"}], "application_number": "NDA219097", "marketing_category": "NDA", "marketing_start_date": "20241219", "listing_expiration_date": "20261231"}