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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
- ndc1149502806877 POUCH in 1 CARTON (49502-806-87) / 1 VIAL, SINGLE-DOSE in 1 POUCH (49502-806-33) / 3 mL in 1 VIAL, SINGLE-DOSE
- ndc11495028069330 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"
}Access this data programmatically
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