EPINASTINE HYDROCHLORIDE
These highlights do not include all the information needed to use EPINASTINE HCl safely and effectively. See full prescribing information for EPINASTINE HCl. EPINASTINE HCl Ophthalmic Solution 0.05% Initial U.S. Approval: 2003
Approved
Approval ID
0d4ee45c-e58f-4b7c-b389-898f5c27f54d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 9, 2023
Manufacturers
FDA
Somerset Therapeutics, LLC
DUNS: 079947873
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 Code70069-008
Application NumberANDA090951
Product Classification
M
Marketing Category
C73584
G
Generic Name
EPINASTINE HYDROCHLORIDE
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 9, 2023
FDA Product Classification
INGREDIENTS (8)
EPINASTINE HYDROCHLORIDEActive
Quantity: 0.5 mg in 1 mL
Code: GFM415S5XL
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Quantity: 0.1 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT