yupelri

Generic: revefenacin

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name yupelri
Generic Name revefenacin
Labeler viatris specialty llc
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

revefenacin 175 ug/3mL

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 49502-806
Product ID 49502-806_b7b789a7-deb0-41d7-9c7d-e6cf68d1b893
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210598
Listing Expiration 2026-12-31
Marketing Start 2018-12-03

Pharmacologic Class

Established (EPC)
anticholinergic [epc]
Mechanism of Action
cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49502806
Hyphenated Format 49502-806

Supplemental Identifiers

RxCUI
2102779 2102784
UNII
G2AE2VE07O
NUI
N0000175574 N0000175370

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name yupelri (source: ndc)
Generic Name revefenacin (source: ndc)
Application Number NDA210598 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 175 ug/3mL
source: ndc
Packaging
  • 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
  • 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
source: ndc

Packages (2)

49502-806-87 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 49502-806-93 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

Ingredients (1)

revefenacin (175 ug/3mL)

Linked Drug Pages (1)

YUPELRI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "b7b789a7-deb0-41d7-9c7d-e6cf68d1b893", "openfda": {"nui": ["N0000175574", "N0000175370"], "unii": ["G2AE2VE07O"], "rxcui": ["2102779", "2102784"], "spl_set_id": ["6dfebf04-7c90-436a-9b16-750d3c1ee0a6"], "pharm_class_epc": ["Anticholinergic [EPC]"], "pharm_class_moa": ["Cholinergic Antagonists [MoA]"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "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", "package_ndc": "49502-806-87", "marketing_start_date": "20190101"}, {"sample": false, "description": "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", "package_ndc": "49502-806-93", "marketing_start_date": "20181203"}], "brand_name": "YUPELRI", "product_id": "49502-806_b7b789a7-deb0-41d7-9c7d-e6cf68d1b893", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "49502-806", "generic_name": "revefenacin", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "YUPELRI", "active_ingredients": [{"name": "REVEFENACIN", "strength": "175 ug/3mL"}], "application_number": "NDA210598", "marketing_category": "NDA", "marketing_start_date": "20181203", "listing_expiration_date": "20261231"}