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United States · US · US:80005-112_4b21f36b-78b4-41db-ae59-814076cf5b90
ETRAVIRINE
In shortageOrange BookUNIISPLATC J05AG04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCarnegie Pharmaceuticals LLC
CountryUS (United States)
ATC codeJ05AG04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc118000511212120 TABLET in 1 BOTTLE (80005-112-12)
Annotations
UNII (FDA Substance ID)
0C50HW4FO1
ETRAVIRINE
RxCUI 475969
Orange Book
A215402
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": "80005-112_4b21f36b-78b4-41db-ae59-814076cf5b90",
"productndc": "80005-112",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "215402",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Apr 13, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "002",
"approval_date": "Apr 13, 2022"
}
],
"appl_type": "A"
},
"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": "ANDA215402",
"marketing_category": "ANDA",
"nonproprietary_name": "ETRAVIRINE",
"start_marketing_date": "20220607",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J05AG04.
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