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United States · US · US:49502-806_b7b789a7-deb0-41d7-9c7d-e6cf68d1b893

YUPELRI

Orange BookUNIISPLATC R03BB08

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeR03BB08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4950280687
    7 POUCH in 1 CARTON (49502-806-87) / 1 VIAL, SINGLE-DOSE in 1 POUCH (49502-806-33) / 3 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    4950280693
    30 POUCH in 1 CARTON (49502-806-93) / 1 VIAL, SINGLE-DOSE in 1 POUCH (49502-806-32) / 3 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
G2AE2VE07O
REVEFENACIN
RxCUI 2102775
Orange Book
N210598
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "G2AE2VE07O",
    "rxcui": "2102775",
    "inchikey": "FYDWDCIFZSGNBU-UHFFFAOYSA-N",
    "display_name": "REVEFENACIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "6dfebf04-7c90-436a-9b16-750d3c1ee0a6": {
      "match": "brand_token",
      "title": "YUPELRI (REVEFENACIN) SOLUTION [VIATRIS SPECIALTY LLC]",
      "spl_version": "15",
      "published_date": "2025-02-14"
    }
  },
  "productid": "49502-806_b7b789a7-deb0-41d7-9c7d-e6cf68d1b893",
  "productndc": "49502-806",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "210598",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "175MCG/3ML",
        "product_no": "001",
        "approval_date": "Nov 9, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "REVEFENACIN",
  "proprietary_name": "YUPELRI",
  "active_ingred_unit": "ug/3mL",
  "application_number": "NDA210598",
  "marketing_category": "NDA",
  "nonproprietary_name": "revefenacin",
  "start_marketing_date": "20181203",
  "active_numerator_strength": "175"
}

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