intelence

Generic: etravirine

Labeler: janssen products lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name intelence
Generic Name etravirine
Labeler janssen products lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

etravirine 200 mg/1

Manufacturer
Janssen Products LP

Identifiers & Regulatory

Product NDC 59676-571
Product ID 59676-571_02fc6f4f-330d-b32e-e063-6294a90a028a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022187
Listing Expiration 2026-12-31
Marketing Start 2010-12-22

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 59676571
Hyphenated Format 59676-571

Supplemental Identifiers

RxCUI
754761 758555 1052658 1052660 1250721 1250723
UPC
0359676570011 0359676571018 0359676572015
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 intelence (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 (59676-571-01)
source: ndc

Packages (1)

59676-571-01 60 TABLET in 1 BOTTLE, PLASTIC (59676-571-01)

Ingredients (1)

etravirine (200 mg/1)

Linked Drug Pages (1)

Intelence ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "02fc6f4f-330d-b32e-e063-6294a90a028a", "openfda": {"nui": ["N0000175463", "N0000175460", "N0000009948", "N0000190118", "N0000185504", "N0000182140", "N0000185503"], "upc": ["0359676570011", "0359676571018", "0359676572015"], "unii": ["0C50HW4FO1"], "rxcui": ["754761", "758555", "1052658", "1052660", "1250721", "1250723"], "spl_set_id": ["6a9cbc29-9f15-4b24-8d86-206b82887f3d"], "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": ["Janssen Products LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (59676-571-01)", "package_ndc": "59676-571-01", "marketing_start_date": "20101222"}], "brand_name": "Intelence", "product_id": "59676-571_02fc6f4f-330d-b32e-e063-6294a90a028a", "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": "59676-571", "generic_name": "etravirine", "labeler_name": "Janssen Products LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Intelence", "active_ingredients": [{"name": "ETRAVIRINE", "strength": "200 mg/1"}], "application_number": "NDA022187", "marketing_category": "NDA", "marketing_start_date": "20101222", "listing_expiration_date": "20261231"}