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United States · US · US:70069-848_8d833cc1-60b6-4e31-aff3-2958b8f93d1f
Rilpivirine
Orange BookUNIISPLATC J05AG05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSomerset Therapeutics, LLC
CountryUS (United States)
ATC codeJ05AG05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11700698483030 TABLET, FILM COATED in 1 BOTTLE (70069-848-30)
Annotations
UNII (FDA Substance ID)
212WAX8KDD
RILPIVIRINE HYDROCHLORIDE
RxCUI 1102287
Orange Book
A218798
AB
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": {
"fb109de9-d88d-4405-8dd6-d458cbc387d1": {
"match": "brand_token",
"title": "RILPIVIRINE TABLET, FILM COATED [SOMERSET THERAPEUTICS, LLC]",
"spl_version": "1",
"published_date": "2026-02-09"
}
},
"productid": "70069-848_8d833cc1-60b6-4e31-aff3-2958b8f93d1f",
"productndc": "70069-848",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "218798",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Jan 29, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RILPIVIRINE HYDROCHLORIDE",
"proprietary_name": "Rilpivirine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA218798",
"marketing_category": "ANDA",
"nonproprietary_name": "Rilpivirine",
"start_marketing_date": "20260130",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code J05AG05.
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