EPINASTINE HYDROCHLORIDE
These highlights do not include all the information needed to use EPINASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for EPINASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION. EPINASTINE HYDROCHLORIDE ophthalmic solution Initial U.S. Approval: 2003
Approved
Approval ID
cafe4650-6aa4-4466-9beb-064ee5a0e401
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2018
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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 Code62756-329
Application NumberANDA091626
Product Classification
M
Marketing Category
C73584
G
Generic Name
EPINASTINE HYDROCHLORIDE
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 24, 2018
FDA Product Classification
INGREDIENTS (8)
EPINASTINE HYDROCHLORIDEActive
Quantity: 0.5 mg in 1 mL
Code: GFM415S5XL
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT