Package 0378-5440-93
Brand: emtricitabine, rilpivirine, tenofovir disoproxil fumarate
Generic: emtricitabine, rilpivirine, tenofovir disoproxil fumaratePackage Facts
Identity
Package NDC
0378-5440-93
Digits Only
0378544093
Product NDC
0378-5440
Description
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5440-93)
Marketing
Marketing Status
Brand
emtricitabine, rilpivirine, tenofovir disoproxil fumarate
Generic
emtricitabine, rilpivirine, tenofovir disoproxil fumarate
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "d9a4185e-43fa-4aeb-9b0f-8db01b166038", "openfda": {"nui": ["N0000175462", "M0015066", "N0000009947"], "unii": ["G70B4ETF4S", "212WAX8KDD", "OTT9J7900I"], "rxcui": ["1147334"], "spl_set_id": ["d9a4185e-43fa-4aeb-9b0f-8db01b166038"], "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": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5440-93)", "package_ndc": "0378-5440-93", "marketing_start_date": "20250527"}], "brand_name": "Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate", "product_id": "0378-5440_d9a4185e-43fa-4aeb-9b0f-8db01b166038", "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": "0378-5440", "generic_name": "Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate", "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": "ANDA208452", "marketing_category": "ANDA", "marketing_start_date": "20250527", "listing_expiration_date": "20261231"}