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United States · US · US:59676-570_02fc6f4f-330d-b32e-e063-6294a90a028a
Intelence
In shortageOrange BookUNIIATC J05AG04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJanssen Products LP
CountryUS (United States)
ATC codeJ05AG04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115967657001120 TABLET in 1 BOTTLE, PLASTIC (59676-570-01)
Annotations
UNII (FDA Substance ID)
0C50HW4FO1
ETRAVIRINE
RxCUI 475969
Orange Book
N022187
ABAB
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",
"productid": "59676-570_02fc6f4f-330d-b32e-e063-6294a90a028a",
"productndc": "59676-570",
"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": "Intelence",
"active_ingred_unit": "mg/1",
"application_number": "NDA022187",
"marketing_category": "NDA",
"nonproprietary_name": "etravirine",
"start_marketing_date": "20080118",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J05AG04.
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