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
NDC Product Code70069-008
Application NumberANDA090951
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateNovember 9, 2023
Generic NameEPINASTINE HYDROCHLORIDE
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