FDA.reportPublic FDA data

YUPELRI

Product NDC
49502-806
11-digit product format
495020806
Labeler code
49502
Product ID
49502-806_b7b789a7-deb0-41d7-9c7d-e6cf68d1b893
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
revefenacin
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Viatris Specialty LLC
Application
NDA210598
Marketing category
NDA
Marketing start
2018-12-03
Substance
REVEFENACIN
Active strength
175 ug/3mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
YUPELRI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
REVEFENACIN175 ug/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG2AE2VE07O
Rxcui2102779, 2102784

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fe6e801f-5fad-4cc6-8d00-2e6ccc7359b2Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49502-806-32YUPELRI1 in 1 POUCHSOLUTION115
49502-806-32YUPELRI3 mL in 1 VIAL, SINGLE-DOSESOLUTION315
49502-806-33YUPELRI1 in 1 POUCHSOLUTION115
49502-806-33YUPELRI3 mL in 1 VIAL, SINGLE-DOSESOLUTION315
49502-806-77YUPELRI7 in 1 CARTONSOLUTION715
49502-806-77YUPELRI1 in 1 POUCHSOLUTION115
49502-806-87YUPELRI7 in 1 CARTONSOLUTION715
49502-806-93YUPELRI30 in 1 CARTONSOLUTION3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49502-806-32ML - Milliliter49502-806f98a441c-524b-4bef-9b91-a87ee203820e12018-12-13
49502-806-87ML - Milliliter49502-80632319973-354f-45c5-90ea-6695f50fbb2e12020-04-20
49502-806-93ML - Milliliter49502-806b53390b5-32c5-465c-9560-269f2e6daaee12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49502-806YUPELRI (REVEFENACIN) SOLUTION [VIATRIS SPECIALTY LLC]15Current NDC, Legacy NDC, 8 package rows20250214_6dfebf04-7c90-436a-9b16-750d3c1ee0a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2102779revefenacin 175 MCG in 3 ML Inhalation SolutionPSN6dfebf04-7c90-436a-9b16-750d3c1ee0a615
2102784YUPELRI 175 MCG in 3 ML Inhalation SolutionPSN6dfebf04-7c90-436a-9b16-750d3c1ee0a615
2102784revefenacin 0.0583 MG/ML Inhalation Solution [Yupelri]SBD6dfebf04-7c90-436a-9b16-750d3c1ee0a615
2102779revefenacin 0.0583 MG/ML Inhalation SolutionSCD6dfebf04-7c90-436a-9b16-750d3c1ee0a615
2102779revefenacin 175 MCG per 3 ML Inhalation SolutionSY6dfebf04-7c90-436a-9b16-750d3c1ee0a615
2102784Yupelri 0.0583 MG/ML Inhalation SolutionSY6dfebf04-7c90-436a-9b16-750d3c1ee0a615
2102784Yuperlri 175 MCG per 3 ML Inhalation SolutionSY6dfebf04-7c90-436a-9b16-750d3c1ee0a615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49502-806-32495020806321 in 1 POUCHHistorical
49502-806-33495020806331 in 1 POUCHHistorical
49502-806-77495020806777 POUCH in 1 CARTON (49502-806-77) > 1 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE7 pouch2019-02-222021-06-30NoNoCurrent
49502-806-87495020806877 POUCH in 1 CARTON (49502-806-87) / 1 VIAL, SINGLE-DOSE in 1 POUCH (49502-806-33) / 3 mL in 1 VIAL, SINGLE-DOSE7 pouch2019-01-010000-00-00YesNoCurrent
49502-806-934950208069330 POUCH in 1 CARTON (49502-806-93) / 1 VIAL, SINGLE-DOSE in 1 POUCH (49502-806-32) / 3 mL in 1 VIAL, SINGLE-DOSE30 pouch2018-12-030000-00-00NoNoCurrent