Epinastine Hydrochloride
These highlights do not include all the information needed to use EPINASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION, 0.05% safely and effectively. See full prescribing information for EPINASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION, 0.05% EPINASTINE HYDROCHLORIDE ophthalmic solution, 0.05% Initial U.S. Approval: 2003
Approved
Approval ID
8ff37968-22a1-4904-a139-977463790f12
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 14, 2023
Manufacturers
FDA
Breckenridge Pharmaceutical, Inc.
DUNS: 150554335
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Epinastine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51991-836
Application NumberANDA090870
Product Classification
M
Marketing Category
C73584
G
Generic Name
Epinastine Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 1, 2021
FDA Product Classification
INGREDIENTS (8)
Epinastine HydrochlorideActive
Quantity: 0.5 mg in 1 mL
Code: GFM415S5XL
Classification: ACTIB
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
benzalkonium chlorideInactive
Quantity: 0.1 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
edetate sodiumInactive
Code: MP1J8420LU
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium phosphate, monobasic, anhydrousInactive
Code: KH7I04HPUU
Classification: IACT