etravirine

Generic: etravirine

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name etravirine
Generic Name etravirine
Labeler leading pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

etravirine 100 mg/1

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-285
Product ID 69315-285_f356d1ba-3572-4a79-9846-94ee2030f04b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215402
Listing Expiration 2026-12-31
Marketing Start 2022-06-05

Pharmacologic Class

Established (EPC)
human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitor [epc]
Mechanism of Action
non-nucleoside reverse transcriptase inhibitors [moa] cytochrome p450 3a inducers [moa] cytochrome p450 2c9 inhibitors [moa] cytochrome p450 2c19 inhibitors [moa] p-glycoprotein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315285
Hyphenated Format 69315-285

Supplemental Identifiers

RxCUI
754761 1052658
UNII
0C50HW4FO1
NUI
N0000175463 N0000175460 N0000009948 N0000190118 N0000185504 N0000182140 N0000185503

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 etravirine (source: ndc)
Generic Name etravirine (source: ndc)
Application Number ANDA215402 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE (69315-285-20)
source: ndc

Packages (1)

69315-285-20 120 TABLET in 1 BOTTLE (69315-285-20)

Ingredients (1)

etravirine (100 mg/1)

Linked Drug Pages (1)

ETRAVIRINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f356d1ba-3572-4a79-9846-94ee2030f04b", "openfda": {"nui": ["N0000175463", "N0000175460", "N0000009948", "N0000190118", "N0000185504", "N0000182140", "N0000185503"], "unii": ["0C50HW4FO1"], "rxcui": ["754761", "1052658"], "spl_set_id": ["48ffeac8-38e8-4007-903a-dbffce25d679"], "pharm_class_epc": ["Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (69315-285-20)", "package_ndc": "69315-285-20", "marketing_start_date": "20220605"}], "brand_name": "ETRAVIRINE", "product_id": "69315-285_f356d1ba-3572-4a79-9846-94ee2030f04b", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Non-Nucleoside Analog [EXT]", "Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "69315-285", "generic_name": "ETRAVIRINE", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ETRAVIRINE", "active_ingredients": [{"name": "ETRAVIRINE", "strength": "100 mg/1"}], "application_number": "ANDA215402", "marketing_category": "ANDA", "marketing_start_date": "20220605", "listing_expiration_date": "20261231"}