efavirenz, emtricitabine and tenofovir disoproxil fumarate

Generic: efavirenz, emtricitabine and tenofovir disoproxil fumarate

Labeler: laurus labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name efavirenz, emtricitabine and tenofovir disoproxil fumarate
Generic Name efavirenz, emtricitabine and tenofovir disoproxil fumarate
Labeler laurus labs limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

efavirenz 600 mg/1, emtricitabine 200 mg/1, tenofovir disoproxil fumarate 300 mg/1

Manufacturer
Laurus Labs Limited

Identifiers & Regulatory

Product NDC 42385-915
Product ID 42385-915_590152fa-ff7a-4db5-8e11-394c6b44c3c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213541
Listing Expiration 2026-12-31
Marketing Start 2021-12-22

Pharmacologic Class

Established (EPC)
human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitor [epc] human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc]
Mechanism of Action
non-nucleoside reverse transcriptase inhibitors [moa] cytochrome p450 3a inducers [moa] cytochrome p450 2b6 inducers [moa] cytochrome p450 2c9 inhibitors [moa] cytochrome p450 2c19 inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] nucleoside reverse transcriptase inhibitors [moa]
Chemical Structure
nucleosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42385915
Hyphenated Format 42385-915

Supplemental Identifiers

RxCUI
643066
UNII
JE6H2O27P8 G70B4ETF4S OTT9J7900I
NUI
N0000175463 N0000175460 N0000009948 N0000190118 N0000187064 N0000185504 N0000182140 N0000182141 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 efavirenz, emtricitabine and tenofovir disoproxil fumarate (source: ndc)
Generic Name efavirenz, emtricitabine and tenofovir disoproxil fumarate (source: ndc)
Application Number ANDA213541 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
  • 200 mg/1
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (42385-915-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (42385-915-90)
source: ndc

Packages (2)

42385-915-30 30 TABLET, FILM COATED in 1 BOTTLE (42385-915-30) 42385-915-90 90 TABLET, FILM COATED in 1 BOTTLE (42385-915-90)

Ingredients (3)

efavirenz (600 mg/1) emtricitabine (200 mg/1) tenofovir disoproxil fumarate (300 mg/1)

Linked Drug Pages (1)

Efavirenz, emtricitabine and tenofovir disoproxil fumarate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "590152fa-ff7a-4db5-8e11-394c6b44c3c0", "openfda": {"nui": ["N0000175463", "N0000175460", "N0000009948", "N0000190118", "N0000187064", "N0000185504", "N0000182140", "N0000182141", "N0000175462", "M0015066", "N0000009947"], "unii": ["JE6H2O27P8", "G70B4ETF4S", "OTT9J7900I"], "rxcui": ["643066"], "spl_set_id": ["aca22076-f435-4533-9fcf-566b0734c313"], "pharm_class_cs": ["Nucleosides [CS]"], "pharm_class_epc": ["Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [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 (42385-915-30)", "package_ndc": "42385-915-30", "marketing_start_date": "20211222"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (42385-915-90)", "package_ndc": "42385-915-90", "marketing_start_date": "20211222"}], "brand_name": "Efavirenz, emtricitabine and tenofovir disoproxil fumarate", "product_id": "42385-915_590152fa-ff7a-4db5-8e11-394c6b44c3c0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "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": "42385-915", "generic_name": "Efavirenz, emtricitabine and tenofovir disoproxil fumarate", "labeler_name": "Laurus Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Efavirenz, emtricitabine and tenofovir disoproxil fumarate", "active_ingredients": [{"name": "EFAVIRENZ", "strength": "600 mg/1"}, {"name": "EMTRICITABINE", "strength": "200 mg/1"}, {"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "300 mg/1"}], "application_number": "ANDA213541", "marketing_category": "ANDA", "marketing_start_date": "20211222", "listing_expiration_date": "20261231"}