Package 68462-683-01

Brand: sirolimus

Generic: sirolimus
NDC Package

Package Facts

Identity

Package NDC 68462-683-01
Digits Only 6846268301
Product NDC 68462-683
Description

100 TABLET, FILM COATED in 1 BOTTLE (68462-683-01)

Marketing

Marketing Status
Marketed Since 2020-10-16
Brand sirolimus
Generic sirolimus
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "72132b30-e98c-4f0c-9fb7-ecb63ba18224", "openfda": {"nui": ["N0000175550", "N0000175625", "N0000175624", "N0000175605", "N0000175076"], "upc": ["0368462682012"], "unii": ["W36ZG6FT64"], "rxcui": ["349208", "360110", "905158"], "spl_set_id": ["57fb4d90-3ccb-4a69-af1e-53be83f7a504"], "pharm_class_pe": ["Decreased Immunologic Activity [PE]"], "pharm_class_epc": ["mTOR Inhibitor Immunosuppressant [EPC]", "Kinase Inhibitor [EPC]"], "pharm_class_moa": ["mTOR Inhibitors [MoA]", "Protein Kinase Inhibitors [MoA]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68462-683-01)", "package_ndc": "68462-683-01", "marketing_start_date": "20201016"}], "brand_name": "sirolimus", "product_id": "68462-683_72132b30-e98c-4f0c-9fb7-ecb63ba18224", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Immunologic Activity [PE]", "Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]", "mTOR Inhibitor Immunosuppressant [EPC]", "mTOR Inhibitors [MoA]"], "product_ndc": "68462-683", "generic_name": "sirolimus", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sirolimus", "active_ingredients": [{"name": "SIROLIMUS", "strength": "1 mg/1"}], "application_number": "ANDA208691", "marketing_category": "ANDA", "marketing_start_date": "20201016", "listing_expiration_date": "20271231"}