AZELASTINE HYDROCHLORIDE
479 - Azelastine hydrochloride
Approved
Approval ID
cc7ddac6-95fa-4bc0-824d-f80e404e8d32
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 2, 2025
Manufacturers
FDA
Allegiant Health
DUNS: 079501930
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
AZELASTINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69168-479
Application NumberANDA216421
Product Classification
M
Marketing Category
C73584
G
Generic Name
AZELASTINE HYDROCHLORIDE
Product Specifications
Route of AdministrationNASAL
Effective DateMay 2, 2025
FDA Product Classification
INGREDIENTS (8)
AZELASTINE HYDROCHLORIDEActive
Quantity: 202.5 ug in 1 1
Code: 0L591QR10I
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT