LONHALA- glycopyrrolate solution 
Holopack Verpackungstechnik GmbH

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Glycopyrrolate Inhalation Solution (25 µg/mL)

Lonhala

(glycopyrrolate) inhalation solution, for oral inhalation use

PRINCIPAL DISPLAY PANEL - SHIPPER LABEL

1 carton = 432 pouches

Glycopyrrolate Inhalation Solution (25 µg/mL)

Item No. 401732-001

Lot: UE076

Exp: 03-2019

Caution: For manufacturing, processing, or repacking.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]

432 pouches with two 1.0 ml ampoules each

Carton # 0034

Made in Germany

Sunovion Pharmaceuticals Inc.

Marlborough, MA 01752 USA

glycopyrrolate inhalation 25

LONHALA 
glycopyrrolate solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60940-024
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE25 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Chloride (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60940-024-01432 in 1 CARTON12/05/2017
12 in 1 POUCH
11 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20843712/05/2017
Labeler - Holopack Verpackungstechnik GmbH (313222457)
Establishment
NameAddressID/FEIBusiness Operations
Holopack Verpackungstechnik GmbH343390324manufacture(60940-024)

Revised: 11/2019
Document Id: 568fa74f-a87f-444b-903e-2219515942d4
Set id: de544612-9129-4b79-9aa9-0b06f059cb78
Version: 3
Effective Time: 20191112
 
Holopack Verpackungstechnik GmbH