emtricitabine and tenofovir disoproxil fumarate (59651-165)

Drug Facts

Product Profile

Brand Name emtricitabine and tenofovir disoproxil fumarate

Generic Name emtricitabine and tenofovir disoproxil fumarate

Labeler aurobindo pharma limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

emtricitabine 100 mg/1, tenofovir disoproxil fumarate 150 mg/1

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-165

Product ID 59651-165_a805c27a-1154-4aac-9af8-bbd755be027f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA211640

Listing Expiration 2026-12-31

Marketing Start 2023-03-09

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 59651165

Hyphenated Format 59651-165

Supplemental Identifiers

RxCUI

1744001 1744005 1744009

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 ANDA211640 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

100 mg/1
150 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (59651-165-30)

source: ndc

Packages (1)

59651-165-30 30 TABLET, FILM COATED in 1 BOTTLE (59651-165-30)

Ingredients (2)

emtricitabine (100 mg/1) tenofovir disoproxil fumarate (150 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": "a805c27a-1154-4aac-9af8-bbd755be027f", "openfda": {"nui": ["N0000175462", "M0015066", "N0000009947"], "unii": ["OTT9J7900I", "G70B4ETF4S"], "rxcui": ["1744001", "1744005", "1744009"], "spl_set_id": ["974d2ec8-1b51-4e69-991d-0d5dea8360f4"], "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": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (59651-165-30)", "package_ndc": "59651-165-30", "marketing_start_date": "20230309"}], "brand_name": "Emtricitabine and Tenofovir Disoproxil Fumarate", "product_id": "59651-165_a805c27a-1154-4aac-9af8-bbd755be027f", "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": "59651-165", "generic_name": "Emtricitabine and Tenofovir Disoproxil Fumarate", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Emtricitabine and Tenofovir Disoproxil Fumarate", "active_ingredients": [{"name": "EMTRICITABINE", "strength": "100 mg/1"}, {"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "150 mg/1"}], "application_number": "ANDA211640", "marketing_category": "ANDA", "marketing_start_date": "20230309", "listing_expiration_date": "20261231"}