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United States · US · US:60219-1722_d93c4af1-6f7d-4744-8b1e-21d89a5f5c9b
etravirine
In shortageOrange BookUNIISPLATC J05AG04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeJ05AG04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11602191722660 TABLET in 1 BOTTLE, PLASTIC (60219-1722-6)
Annotations
UNII (FDA Substance ID)
0C50HW4FO1
ETRAVIRINE
RxCUI 475969
Orange Book
A214196
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": "60219-1722_d93c4af1-6f7d-4744-8b1e-21d89a5f5c9b",
"productndc": "60219-1722",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214196",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "25MG",
"product_no": "001",
"approval_date": "Jun 14, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "Jun 14, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "003",
"approval_date": "Jun 14, 2021"
}
],
"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": "ANDA214196",
"marketing_category": "ANDA",
"nonproprietary_name": "etravirine",
"start_marketing_date": "20210614",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code J05AG04.
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