emtricitabine and tenofovir disoproxil fumarate (42385-953)

Drug Facts

Product Profile

Brand Name emtricitabine and tenofovir disoproxil fumarate

Generic Name emtricitabine and tenofovir disoproxil fumarate

Labeler laurus labs limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

Laurus Labs Limited

Identifiers & Regulatory

Product NDC 42385-953

Product ID 42385-953_bf69c830-aa6f-4813-8421-6b3bd689086d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212114

Listing Expiration 2026-12-31

Marketing Start 2019-07-26

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 42385953

Hyphenated Format 42385-953

Supplemental Identifiers

RxCUI

476556

UPC

0342385953305

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 ANDA212114 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

200 mg/1
300 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (42385-953-30)
90 TABLET, FILM COATED in 1 BOTTLE (42385-953-90)

source: ndc

Packages (2)

42385-953-30 30 TABLET, FILM COATED in 1 BOTTLE (42385-953-30) 42385-953-90 90 TABLET, FILM COATED in 1 BOTTLE (42385-953-90)

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": "bf69c830-aa6f-4813-8421-6b3bd689086d", "openfda": {"nui": ["N0000175462", "M0015066", "N0000009947"], "upc": ["0342385953305"], "unii": ["G70B4ETF4S", "OTT9J7900I"], "rxcui": ["476556"], "spl_set_id": ["4a7ccbbf-da20-4012-9717-31c411efb3fb"], "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": ["Laurus Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42385-953-30)", "package_ndc": "42385-953-30", "marketing_start_date": "20190726"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (42385-953-90)", "package_ndc": "42385-953-90", "marketing_start_date": "20190726"}], "brand_name": "Emtricitabine and Tenofovir Disoproxil Fumarate", "product_id": "42385-953_bf69c830-aa6f-4813-8421-6b3bd689086d", "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": "42385-953", "generic_name": "Emtricitabine and Tenofovir Disoproxil Fumarate", "labeler_name": "Laurus Labs 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": "ANDA212114", "marketing_category": "ANDA", "marketing_start_date": "20190726", "listing_expiration_date": "20261231"}