Package 0378-5440-93

Brand: emtricitabine, rilpivirine, tenofovir disoproxil fumarate

Generic: emtricitabine, rilpivirine, tenofovir disoproxil fumarate
NDC Package

Package 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
Marketed Since 2025-05-27
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"}