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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

  • ndc11
    7006984830
    30 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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