Package 68382-921-16
Brand: entecavir
Generic: entecavirPackage Facts
Identity
Package NDC
68382-921-16
Digits Only
6838292116
Product NDC
68382-921
Description
90 TABLET, FILM COATED in 1 BOTTLE (68382-921-16)
Marketing
Marketing Status
Brand
entecavir
Generic
entecavir
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "b9646f09-8d5b-4271-b2b1-b1d66a91ed73", "openfda": {"unii": ["5968Y6H45M"], "rxcui": ["485434", "485436"], "spl_set_id": ["b4fd0e22-ad23-4f51-9b98-95182f63c2eb"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68382-921-01)", "package_ndc": "68382-921-01", "marketing_start_date": "20170810"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68382-921-06)", "package_ndc": "68382-921-06", "marketing_start_date": "20170810"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68382-921-16)", "package_ndc": "68382-921-16", "marketing_start_date": "20170810"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-921-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-921-30)", "package_ndc": "68382-921-77", "marketing_start_date": "20170810"}], "brand_name": "Entecavir", "product_id": "68382-921_b9646f09-8d5b-4271-b2b1-b1d66a91ed73", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Analog [EXT]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "68382-921", "generic_name": "Entecavir", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Entecavir", "active_ingredients": [{"name": "ENTECAVIR", "strength": "1 mg/1"}], "application_number": "ANDA206745", "marketing_category": "ANDA", "marketing_start_date": "20170810", "listing_expiration_date": "20261231"}