IOPIDINE 1%
IOPIDINE 1% (apraclonidine hydrochloride ophthalmic solution) 1% as base Sterile
Approved
Approval ID
00f18845-ccde-8678-e063-6294a90a3374
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 31, 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.
apraclonidine hydrochloride ophthalmic solution
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82667-200
Application NumberNDA019779
Product Classification
M
Marketing Category
C73594
G
Generic Name
apraclonidine hydrochloride ophthalmic solution
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 31, 2023
FDA Product Classification
INGREDIENTS (7)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
APRACLONIDINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: D2VW67N38H
Classification: ACTIM