etravirine

Generic: etravirine

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name etravirine
Generic Name etravirine
Labeler bionpharma inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

etravirine 100 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-254
Product ID 69452-254_458bb39e-2e86-b4b4-e063-6394a90ae867
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219152
Listing Expiration 2026-12-31
Marketing Start 2026-01-01

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 69452254
Hyphenated Format 69452-254

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 ANDA219152 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE, PLASTIC (69452-254-22)
source: ndc

Packages (1)

69452-254-22 120 TABLET in 1 BOTTLE, PLASTIC (69452-254-22)

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": "458bb39e-2e86-b4b4-e063-6394a90ae867", "openfda": {"nui": ["N0000175463", "N0000175460", "N0000009948", "N0000190118", "N0000185504", "N0000182140", "N0000185503"], "unii": ["0C50HW4FO1"], "rxcui": ["754761", "1052658"], "spl_set_id": ["458bb39e-2e87-b4b4-e063-6394a90ae867"], "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": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE, PLASTIC (69452-254-22)", "package_ndc": "69452-254-22", "marketing_start_date": "20260101"}], "brand_name": "etravirine", "product_id": "69452-254_458bb39e-2e86-b4b4-e063-6394a90ae867", "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": "69452-254", "generic_name": "etravirine", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "etravirine", "active_ingredients": [{"name": "ETRAVIRINE", "strength": "100 mg/1"}], "application_number": "ANDA219152", "marketing_category": "ANDA", "marketing_start_date": "20260101", "listing_expiration_date": "20261231"}