Package 61958-1101-1
Brand: complera
Generic: emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumaratePackage Facts
Identity
Package NDC
61958-1101-1
Digits Only
6195811011
Product NDC
61958-1101
Description
30 TABLET, FILM COATED in 1 BOTTLE (61958-1101-1)
Marketing
Marketing Status
Brand
complera
Generic
emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "21d7850d-11ea-43cc-84a5-0dae02a19ce6", "openfda": {"nui": ["N0000175462", "M0015066", "N0000009947"], "unii": ["G70B4ETF4S", "212WAX8KDD", "OTT9J7900I"], "rxcui": ["1147334", "1147337"], "spl_set_id": ["d637cfab-f1e8-4eb3-a1b3-f85ca3bec612"], "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, FILM COATED in 1 BOTTLE (61958-1101-1)", "package_ndc": "61958-1101-1", "marketing_start_date": "20110810"}], "brand_name": "COMPLERA", "product_id": "61958-1101_21d7850d-11ea-43cc-84a5-0dae02a19ce6", "dosage_form": "TABLET, FILM COATED", "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": "61958-1101", "generic_name": "emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate", "labeler_name": "Gilead Sciences, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "COMPLERA", "active_ingredients": [{"name": "EMTRICITABINE", "strength": "200 mg/1"}, {"name": "RILPIVIRINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "300 mg/1"}], "application_number": "NDA202123", "marketing_category": "NDA", "marketing_start_date": "20110810", "listing_expiration_date": "20261231"}