etravirine

Generic: etravirine

Labeler: patriot pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name etravirine
Generic Name etravirine
Labeler patriot pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

etravirine 200 mg/1

Manufacturer
Patriot Pharmaceuticals

Identifiers & Regulatory

Product NDC 10147-0571
Product ID 10147-0571_31cddc7a-0154-c49a-e063-6394a90a1a49
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022187
Listing Expiration 2026-12-31
Marketing Start 2025-04-01

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 101470571
Hyphenated Format 10147-0571

Supplemental Identifiers

RxCUI
754761 1052658
UPC
0310147057110 0310147057011
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 NDA022187 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE, PLASTIC (10147-0571-1)
source: ndc

Packages (1)

10147-0571-1 60 TABLET in 1 BOTTLE, PLASTIC (10147-0571-1)

Ingredients (1)

etravirine (200 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": "31cddc7a-0154-c49a-e063-6394a90a1a49", "openfda": {"nui": ["N0000175463", "N0000175460", "N0000009948", "N0000190118", "N0000185504", "N0000182140", "N0000185503"], "upc": ["0310147057110", "0310147057011"], "unii": ["0C50HW4FO1"], "rxcui": ["754761", "1052658"], "spl_set_id": ["50ca19cb-0f43-4d7b-8c9e-8b3aaded0546"], "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": ["Patriot Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (10147-0571-1)", "package_ndc": "10147-0571-1", "marketing_start_date": "20250401"}], "brand_name": "Etravirine", "product_id": "10147-0571_31cddc7a-0154-c49a-e063-6394a90a1a49", "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": "10147-0571", "generic_name": "etravirine", "labeler_name": "Patriot Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Etravirine", "active_ingredients": [{"name": "ETRAVIRINE", "strength": "200 mg/1"}], "application_number": "NDA022187", "marketing_category": "NDA", "marketing_start_date": "20250401", "listing_expiration_date": "20261231"}