emtricitabine and tenofovir disoproxil fumarate (69238-2093)

Drug Facts

Product Profile

Brand Name emtricitabine and tenofovir disoproxil fumarate

Generic Name emtricitabine and tenofovir disoproxil fumarate

Labeler amneal pharmaceuticals ny llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

emtricitabine 133 mg/1, tenofovir disoproxil fumarate 200 mg/1

Manufacturer

Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-2093

Product ID 69238-2093_e3f72707-b2b3-49e4-8b28-a9311e1358cf

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA209721

Listing Expiration 2026-12-31

Marketing Start 2018-08-26

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 692382093

Hyphenated Format 69238-2093

Supplemental Identifiers

RxCUI

476556 1744001 1744005 1744009

UPC

0369238209433 0369238209532 0369238209235 0369238209334

UNII

OTT9J7900I G70B4ETF4S

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 and tenofovir disoproxil fumarate (source: ndc)

Generic Name emtricitabine and tenofovir disoproxil fumarate (source: ndc)

Application Number ANDA209721 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

133 mg/1
200 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (69238-2093-3)

source: ndc

Packages (1)

69238-2093-3 30 TABLET, FILM COATED in 1 BOTTLE (69238-2093-3)

Ingredients (2)

emtricitabine (133 mg/1) tenofovir disoproxil fumarate (200 mg/1)

Linked Drug Pages (1)

Emtricitabine and Tenofovir Disoproxil Fumarate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "e3f72707-b2b3-49e4-8b28-a9311e1358cf", "openfda": {"nui": ["N0000175462", "M0015066", "N0000009947"], "upc": ["0369238209433", "0369238209532", "0369238209235", "0369238209334"], "unii": ["OTT9J7900I", "G70B4ETF4S"], "rxcui": ["476556", "1744001", "1744005", "1744009"], "spl_set_id": ["b0459301-2bff-4336-9172-b90c7a582433"], "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": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (69238-2093-3)", "package_ndc": "69238-2093-3", "marketing_start_date": "20180826"}], "brand_name": "Emtricitabine and Tenofovir Disoproxil Fumarate", "product_id": "69238-2093_e3f72707-b2b3-49e4-8b28-a9311e1358cf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleosides [CS]", "Nucleosides [CS]"], "product_ndc": "69238-2093", "generic_name": "Emtricitabine and Tenofovir Disoproxil Fumarate", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Emtricitabine and Tenofovir Disoproxil Fumarate", "active_ingredients": [{"name": "EMTRICITABINE", "strength": "133 mg/1"}, {"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "200 mg/1"}], "application_number": "ANDA209721", "marketing_category": "ANDA", "marketing_start_date": "20180826", "listing_expiration_date": "20261231"}