Package 61958-2101-1

Brand: odefsey

Generic: emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide
NDC Package

Package Facts

Identity

Package NDC 61958-2101-1
Digits Only 6195821011
Product NDC 61958-2101
Description

30 TABLET in 1 BOTTLE, PLASTIC (61958-2101-1)

Marketing

Marketing Status
Marketed Since 2016-03-01
Brand odefsey
Generic emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "130b8bbc-f660-40ff-831c-139734f90b99", "openfda": {"nui": ["N0000175462", "M0015066", "N0000009947"], "unii": ["G70B4ETF4S", "212WAX8KDD", "FWF6Q91TZO"], "rxcui": ["1741733", "1741739"], "spl_set_id": ["ea3b9ec8-e04a-412c-8b3f-e5cbc7e641d5"], "pharm_class_cs": ["Nucleosides [CS]"], "pharm_class_epc": ["Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "manufacturer_name": ["Gilead Sciences, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (61958-2101-1)", "package_ndc": "61958-2101-1", "marketing_start_date": "20160301"}], "brand_name": "ODEFSEY", "product_id": "61958-2101_130b8bbc-f660-40ff-831c-139734f90b99", "dosage_form": "TABLET", "pharm_class": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Non-Nucleoside Analog [EXT]", "Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleosides [CS]", "Nucleosides [CS]"], "product_ndc": "61958-2101", "generic_name": "emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide", "labeler_name": "Gilead Sciences, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ODEFSEY", "active_ingredients": [{"name": "EMTRICITABINE", "strength": "200 mg/1"}, {"name": "RILPIVIRINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "TENOFOVIR ALAFENAMIDE FUMARATE", "strength": "25 mg/1"}], "application_number": "NDA208351", "marketing_category": "NDA", "marketing_start_date": "20160301", "listing_expiration_date": "20261231"}