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United States · US · US:59676-280_3d6d0fcc-0b62-b76b-e063-6294a90aea43
EDURANT PED
Orange BookUNIISPLATC J05AG05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJanssen Products, LP
CountryUS (United States)
ATC codeJ05AG05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159676280909 BLISTER PACK in 1 CARTON (59676-280-90) / 10 TABLET, FOR SUSPENSION in 1 BLISTER PACK (59676-280-01)
Annotations
UNII (FDA Substance ID)
212WAX8KDD
RILPIVIRINE HYDROCHLORIDE
RxCUI 1102287
Orange Book
N219016
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "212WAX8KDD",
"rxcui": "1102287",
"inchikey": "KZVVGZKAVZUACK-BJILWQEISA-N",
"display_name": "RILPIVIRINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"03880372-2c68-45c6-a53a-f420c49541d6": {
"match": "brand_token",
"title": "EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED EDURANT PED (RILPIVIRINE HYDROCHLORIDE) TABLET, FOR SUSPENSION [JANSSEN PRODUCTS, LP]",
"spl_version": "28",
"published_date": "2025-09-01"
}
},
"productid": "59676-280_3d6d0fcc-0b62-b76b-e063-6294a90aea43",
"productndc": "59676-280",
"dosage_form": "TABLET, FOR SUSPENSION",
"orange_book": {
"appl_no": "219016",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 2.5MG BASE",
"product_no": "001",
"approval_date": "Mar 15, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RILPIVIRINE HYDROCHLORIDE",
"proprietary_name": "EDURANT PED",
"active_ingred_unit": "mg/1",
"application_number": "NDA219016",
"marketing_category": "NDA",
"nonproprietary_name": "rilpivirine hydrochloride",
"start_marketing_date": "20240315",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code J05AG05.
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