Label: AZELASTINE HYDROCHLORIDE spray, metered
- NDC Code(s): 70771-1313-2
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 13, 2022
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INGREDIENTS AND APPEARANCE
AZELASTINE HYDROCHLORIDE
azelastine hydrochloride spray, meteredProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1313 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZELASTINE HYDROCHLORIDE (UNII: 0L591QR10I) (AZELASTINE - UNII:ZQI909440X) AZELASTINE HYDROCHLORIDE 137 ug Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1313-2 1 in 1 CARTON 02/01/2018 1 200 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091409 02/01/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1313) , MANUFACTURE(70771-1313)
