emtricitabine, rilpivirine, tenofovir disoproxil fumarate (0378-5440)

Drug Facts

Product Profile

Brand Name emtricitabine, rilpivirine, tenofovir disoproxil fumarate

Generic Name emtricitabine, rilpivirine, tenofovir disoproxil fumarate

Labeler mylan pharmaceuticals inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

emtricitabine 200 mg/1, rilpivirine hydrochloride 25 mg/1, tenofovir disoproxil fumarate 300 mg/1

Manufacturer

Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-5440

Product ID 0378-5440_d9a4185e-43fa-4aeb-9b0f-8db01b166038

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA208452

Listing Expiration 2026-12-31

Marketing Start 2025-05-27

Pharmacologic Class

Established (EPC)

human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc]

Mechanism of Action

nucleoside reverse transcriptase inhibitors [moa]

Chemical Structure

nucleosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03785440

Hyphenated Format 0378-5440

Supplemental Identifiers

RxCUI

1147334

UNII

G70B4ETF4S 212WAX8KDD OTT9J7900I

NUI

N0000175462 M0015066 N0000009947

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name emtricitabine, rilpivirine, tenofovir disoproxil fumarate (source: ndc)

Generic Name emtricitabine, rilpivirine, tenofovir disoproxil fumarate (source: ndc)

Application Number ANDA208452 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

200 mg/1
25 mg/1
300 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5440-93)

source: ndc

Packages (1)

0378-5440-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5440-93)

Ingredients (3)

emtricitabine (200 mg/1) rilpivirine hydrochloride (25 mg/1) tenofovir disoproxil fumarate (300 mg/1)

Linked Drug Pages (1)

Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate ndc-match (0.9)

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"}