AZELASTINE HYDROCHLORIDE - azelastine hydrochloride spray, metered 
Zydus Lifesciences Limited

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AZELASTINE hydrochloride nasal solution (nasal spray), 137 mcg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1313-2

Azelastine Hydrochloride Nasal Spray, 137 mcg per spray

30 mL

Rx only

Azelastine hydrochloride nasal spray
AZELASTINE HYDROCHLORIDE 
azelastine hydrochloride spray, metered
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1313
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AZELASTINE HYDROCHLORIDE (UNII: 0L591QR10I) (AZELASTINE - UNII:ZQI909440X) AZELASTINE HYDROCHLORIDE137 ug
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1313-21 in 1 CARTON02/01/2018
1200 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09140902/01/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1313) , MANUFACTURE(70771-1313)

Revised: 10/2022
Document Id: ca74e118-c739-4a6b-aee8-a32132d43374
Set id: b8d32cf2-8068-4659-b088-ee51cbf18604
Version: 5
Effective Time: 20221013
 
Zydus Lifesciences Limited