Yupelri

YUPELRI- revefenacin solution
The Ritedose Corporation

Contents:
Each vial contains 175 mcg of revefenacin in an isotonic, sterile aqueous solution containing sodium chloride, citric acid and sodium citrate.

Storage:
Store YUPELRI (revefenacin) inhalation solution in the protective foil pouch. Store at room temperature from 68°F to 77°F (20°C to 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature].Protect from direct sunlight and excessive heat. The YUPELRI unit-dose vial should only be removed from the foil pouch and opened IMMEDIATELY BEFORE USE. The vial and any residual content should be discarded after use. Discard any solution that is not clear and colorless. Use only as directed by your healthcare provider.

Keep out of reach of children. Not a child-resistant package.

Manufactured for:
Mylan Specialty L.P.
Morgantown, WV 26505 USA

Made in USA

Licensed from:
Theravance Biopharma Ireland Limited

Copyright © 2018 Mylan Specialty L.P. All rights reserved.
YUPELRI is a registered trademark of Mylan Specialty L.P., Morgantown, WV 26505 USA
Patented. See YUPELRI.com/patents

Principal Display Panel — Mylan Yupelri 175 mcg 7 ct Singles Trade Shelf Carton

NDC 49502-806-77 Rx only

YUPELRI (revefenacin) inihalation solution 175 mcg/3 mL

For Oral Inhalation Only

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

7 sterile unit-dose vials

Theravance Biopharma

Mylan

7 ct singles carton
(click image for full-size original)

Principal Display Panel — Mylan Yupelri 175 mcg 30 ct Singles Trade Shelf Carton

NDC 49502-806-93 Rx only

YUPELRI (revefenacin) inihalation solution 175 mcg/3 mL

For Oral Inhalation Only

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

30 sterile unit-dose vials

Theravance Biopharma

Mylan

30 ct singles carton
(click image for full-size original)
YUPELRI
revefenacin solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65302-043
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
REVEFENACIN (REVEFENACIN) REVEFENACIN 175 ug in 3 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65302-043-07 7 POUCH in 1 CARTON contains a POUCH
1 1 VIAL, SINGLE-DOSE in 1 POUCH This package is contained within the CARTON (65302-043-07) and contains a VIAL, SINGLE-DOSE
1 3 mL in 1 VIAL, SINGLE-DOSE This package is contained within a POUCH and a CARTON (65302-043-07)
2 NDC:65302-043-30 30 POUCH in 1 CARTON contains a POUCH
2 1 VIAL, SINGLE-DOSE in 1 POUCH This package is contained within the CARTON (65302-043-30) and contains a VIAL, SINGLE-DOSE
2 3 mL in 1 VIAL, SINGLE-DOSE This package is contained within a POUCH and a CARTON (65302-043-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210598 12/03/2018
Labeler — The Ritedose Corporation (837769546)
Establishment
Name Address ID/FEI Operations
The Ritedose Corporation 837769546 analysis (65302-043), manufacture (65302-043), pack (65302-043), label (65302-043)

Revised: 12/2018 The Ritedose Corporation

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