emtricitabine and tenofovir disoproxil fumarate (64380-719)

Drug Facts

Product Profile

Brand Name emtricitabine and tenofovir disoproxil fumarate

Generic Name emtricitabine and tenofovir disoproxil fumarate

Labeler strides pharma science limited

Dosage Form TABLET

Routes

ORAL

Active Ingredients

emtricitabine 200 mg/1, tenofovir disoproxil fumarate 300 mg/1

Manufacturer

Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-719

Product ID 64380-719_bf6c27ef-5fde-4c9f-82b2-fbf0797bd359

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA091055

Listing Expiration 2027-12-31

Marketing Start 2021-03-30

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 64380719

Hyphenated Format 64380-719

Supplemental Identifiers

RxCUI

476556

UPC

0364380719045

UNII

G70B4ETF4S 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 and tenofovir disoproxil fumarate (source: ndc)

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

Application Number ANDA091055 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

200 mg/1
300 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE, PLASTIC (64380-719-04)

source: ndc

Packages (1)

64380-719-04 30 TABLET in 1 BOTTLE, PLASTIC (64380-719-04)

Ingredients (2)

emtricitabine (200 mg/1) tenofovir disoproxil fumarate (300 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": "bf6c27ef-5fde-4c9f-82b2-fbf0797bd359", "openfda": {"nui": ["N0000175462", "M0015066", "N0000009947"], "upc": ["0364380719045"], "unii": ["G70B4ETF4S", "OTT9J7900I"], "rxcui": ["476556"], "spl_set_id": ["bc37cba9-83c8-4660-a527-cd77fae9ea87"], "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": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (64380-719-04)", "package_ndc": "64380-719-04", "marketing_start_date": "20210330"}], "brand_name": "Emtricitabine and Tenofovir Disoproxil Fumarate", "product_id": "64380-719_bf6c27ef-5fde-4c9f-82b2-fbf0797bd359", "dosage_form": "TABLET", "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": "64380-719", "generic_name": "EMTRICITABINE and TENOFOVIR Disoproxil Fumarate", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Emtricitabine and Tenofovir Disoproxil Fumarate", "active_ingredients": [{"name": "EMTRICITABINE", "strength": "200 mg/1"}, {"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "300 mg/1"}], "application_number": "ANDA091055", "marketing_category": "ANDA", "marketing_start_date": "20210330", "listing_expiration_date": "20271231"}