Package 0078-0649-13
Brand: gleevec
Generic: imatinib mesylatePackage Facts
Identity
Package NDC
0078-0649-13
Digits Only
0078064913
Product NDC
0078-0649
Description
3 BLISTER PACK in 1 CARTON (0078-0649-13) / 10 TABLET in 1 BLISTER PACK (0078-0649-26)
Marketing
Marketing Status
Brand
gleevec
Generic
imatinib mesylate
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "cbc7561e-5e16-4e05-9c07-52626c43eafc", "openfda": {"unii": ["8A1O1M485B"], "rxcui": ["403878", "403879", "404588", "404589"], "spl_set_id": ["211ef2da-2868-4a77-8055-1cb2cd78e24b"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (0078-0649-13) / 10 TABLET in 1 BLISTER PACK (0078-0649-26)", "package_ndc": "0078-0649-13", "marketing_start_date": "20240301"}, {"sample": false, "description": "30 TABLET in 1 BOX, UNIT-DOSE (0078-0649-30)", "package_ndc": "0078-0649-30", "marketing_end_date": "20261231", "marketing_start_date": "20141223"}], "brand_name": "Gleevec", "product_id": "0078-0649_cbc7561e-5e16-4e05-9c07-52626c43eafc", "dosage_form": "TABLET", "pharm_class": ["Bcr-Abl Tyrosine Kinase Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Kinase Inhibitor [EPC]"], "product_ndc": "0078-0649", "generic_name": "imatinib mesylate", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gleevec", "active_ingredients": [{"name": "IMATINIB MESYLATE", "strength": "400 mg/1"}], "application_number": "NDA021588", "marketing_category": "NDA", "marketing_start_date": "20141223", "listing_expiration_date": "20271231"}