NDC 49502-806

YUPELRI

Revefenacin

YUPELRI is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Specialty L.p.. The primary component is Revefenacin.

Product ID49502-806_10a82af1-5439-42be-b133-7ac409784ea9
NDC49502-806
Product TypeHuman Prescription Drug
Proprietary NameYUPELRI
Generic NameRevefenacin
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2018-12-03
Marketing CategoryNDA / NDA
Application NumberNDA210598
Labeler NameMylan Specialty L.P.
Substance NameREVEFENACIN
Active Ingredient Strength175 ug/3mL
Pharm ClassesAnticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 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
Marketing Start Date2019-01-01
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 49502-806-87 [49502080687]

YUPELRI SOLUTION
Marketing CategoryNDA
Application NumberNDA210598
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-01-01

NDC 49502-806-93 [49502080693]

YUPELRI SOLUTION
Marketing CategoryNDA
Application NumberNDA210598
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-12-03

NDC 49502-806-32 [49502080632]

YUPELRI SOLUTION
Marketing CategoryNDA
Application NumberNDA210598
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-12-03

NDC 49502-806-33 [49502080633]

YUPELRI SOLUTION
Marketing CategoryNDA
Application NumberNDA210598
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-03

NDC 49502-806-77 [49502080677]

YUPELRI SOLUTION
Marketing CategoryNDA
Application NumberNDA210598
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-22

Drug Details

Active Ingredients

IngredientStrength
REVEFENACIN175 ug/3mL

OpenFDA Data

SPL SET ID:6dfebf04-7c90-436a-9b16-750d3c1ee0a6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2102784
  • 2102779

  • Trademark Results [YUPELRI]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    YUPELRI
    YUPELRI
    87751266 not registered Live/Pending
    Mylan Specialty L.P.
    2018-01-11

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