Etravirine

In shortageOrange BookUNIISPLATC J05AG04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPatriot Pharmaceuticals

CountryUS (United States)

ATC codeJ05AG04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1014705711
60 TABLET in 1 BOTTLE, PLASTIC (10147-0571-1)

Annotations

UNII (FDA Substance ID)

0C50HW4FO1

ETRAVIRINE

RxCUI 475969

Orange Book

N022187

ABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Etravirine Tablet

Raw payload (JSON)

{
  "unii": {
    "unii": "0C50HW4FO1",
    "rxcui": "475969",
    "inchikey": "PYGWGZALEOIKDF-UHFFFAOYSA-N",
    "display_name": "ETRAVIRINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ea3856f6-fedf-ee88-e053-2a95a90a33ce": {
      "match": "brand_token",
      "title": "ETRAVIRINE TABLET [AVKARE]",
      "spl_version": "3",
      "published_date": "2026-01-14"
    }
  },
  "productid": "10147-0571_31cddc7a-0154-c49a-e063-6394a90a1a49",
  "productndc": "10147-0571",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "022187",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jan 18, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Dec 22, 2010"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "25MG",
        "product_no": "003",
        "approval_date": "Mar 26, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETRAVIRINE",
  "shortage_reason": "Etravirine Tablet",
  "shortage_status": "current",
  "proprietary_name": "Etravirine",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022187",
  "marketing_category": "NDA",
  "nonproprietary_name": "etravirine",
  "start_marketing_date": "20250401",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code J05AG04.

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