IHEEZO
These highlights do not include all the information needed to use IHEEZO safely and effectively. See full prescribing information for IHEEZO . IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3%, for topical ophthalmic use Initial U.S. Approval: 1955
Approved
Approval ID
ea3b2d2c-8b33-d199-e053-2995a90a699c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 21, 2023
Manufacturers
FDA
Harrow Eye, LLC
DUNS: 118526951
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
chloroprocaine hydrochloride ophthalmic gel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82667-300
Application NumberNDA216227
Product Classification
M
Marketing Category
C73594
G
Generic Name
chloroprocaine hydrochloride ophthalmic gel
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateFebruary 21, 2023
FDA Product Classification
INGREDIENTS (4)
CHLOROPROCAINE HYDROCHLORIDEActive
Quantity: 24 mg in 800 mg
Code: LT7Z1YW11H
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive
Code: T4V6TWG28D
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT