Package 61958-1801-1
Brand: harvoni
Generic: ledipasvir and sofosbuvirPackage Facts
Identity
Package NDC
61958-1801-1
Digits Only
6195818011
Product NDC
61958-1801
Description
28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1801-1)
Marketing
Marketing Status
Brand
harvoni
Generic
ledipasvir and sofosbuvir
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "6fc15183-879a-4402-af66-edf57754e31f", "openfda": {"nui": ["N0000191493", "N0000191258", "N0000191256", "N0000185503", "N0000190113"], "unii": ["WJ6CA3ZU8B", "013TE6E4WV"], "rxcui": ["1591943", "1591949", "2203895", "2203897", "2204100", "2204102", "2204103", "2204104"], "spl_set_id": ["f4ec77e4-bae8-4db0-b3d5-bde09c5fa075"], "pharm_class_epc": ["Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]", "Hepatitis C Virus NS5A Inhibitor [EPC]"], "pharm_class_moa": ["RNA Replicase Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]"], "manufacturer_name": ["Gilead Sciences, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1801-1)", "package_ndc": "61958-1801-1", "marketing_start_date": "20141010"}], "brand_name": "Harvoni", "product_id": "61958-1801_6fc15183-879a-4402-af66-edf57754e31f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Hepatitis C Virus NS5A Inhibitor [EPC]", "Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]", "P-Glycoprotein Inhibitors [MoA]", "RNA Replicase Inhibitors [MoA]"], "product_ndc": "61958-1801", "generic_name": "LEDIPASVIR and SOFOSBUVIR", "labeler_name": "Gilead Sciences, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Harvoni", "active_ingredients": [{"name": "LEDIPASVIR", "strength": "90 mg/1"}, {"name": "SOFOSBUVIR", "strength": "400 mg/1"}], "application_number": "NDA205834", "marketing_category": "NDA", "marketing_start_date": "20141010", "listing_expiration_date": "20261231"}