efavirenz, lamivudine and tenofovir disoproxil fumarate

Generic: efavirenz, lamivudine and tenofovir disoproxil fumarate

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

Drug Facts

Product Profile

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

efavirenz 600 mg/1, lamivudine 300 mg/1, tenofovir disoproxil fumarate 300 mg/1

Manufacturer
Laurus Labs Limited

Identifiers & Regulatory

Product NDC 42385-928
Product ID 42385-928_27623aed-629d-4406-a0bf-4f234fc4e6c6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212786
Listing Expiration 2026-12-31
Marketing Start 2020-05-14

Pharmacologic Class

Established (EPC)
human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitor [epc] hepatitis b virus 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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42385928
Hyphenated Format 42385-928

Supplemental Identifiers

RxCUI
864661
UNII
JE6H2O27P8 2T8Q726O95 OTT9J7900I
NUI
N0000175463 N0000175460 N0000009948 N0000190118 N0000187064 N0000185504 N0000182140 N0000182141 N0000175656 N0000175462 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, lamivudine and tenofovir disoproxil fumarate (source: ndc)
Generic Name efavirenz, lamivudine and tenofovir disoproxil fumarate (source: ndc)
Application Number ANDA212786 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (42385-928-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (42385-928-90)
source: ndc

Packages (2)

42385-928-30 30 TABLET, FILM COATED in 1 BOTTLE (42385-928-30) 42385-928-90 90 TABLET, FILM COATED in 1 BOTTLE (42385-928-90)

Ingredients (3)

efavirenz (600 mg/1) lamivudine (300 mg/1) tenofovir disoproxil fumarate (300 mg/1)

Linked Drug Pages (1)

Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "27623aed-629d-4406-a0bf-4f234fc4e6c6", "openfda": {"nui": ["N0000175463", "N0000175460", "N0000009948", "N0000190118", "N0000187064", "N0000185504", "N0000182140", "N0000182141", "N0000175656", "N0000175462", "N0000009947"], "unii": ["JE6H2O27P8", "2T8Q726O95", "OTT9J7900I"], "rxcui": ["864661"], "spl_set_id": ["1f8f9fe1-b8fd-4f65-8832-9d3d6802d076"], "pharm_class_epc": ["Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Hepatitis B Virus 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 (42385-928-30)", "package_ndc": "42385-928-30", "marketing_start_date": "20200514"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (42385-928-90)", "package_ndc": "42385-928-90", "marketing_start_date": "20200514"}], "brand_name": "Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate", "product_id": "42385-928_27623aed-629d-4406-a0bf-4f234fc4e6c6", "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]", "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]"], "product_ndc": "42385-928", "generic_name": "Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate", "labeler_name": "Laurus Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate", "active_ingredients": [{"name": "EFAVIRENZ", "strength": "600 mg/1"}, {"name": "LAMIVUDINE", "strength": "300 mg/1"}, {"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "300 mg/1"}], "application_number": "ANDA212786", "marketing_category": "ANDA", "marketing_start_date": "20200514", "listing_expiration_date": "20261231"}