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
NDC Product Code82667-200
Application NumberNDA019779
Marketing CategoryC73594
Route of AdministrationOPHTHALMIC
Effective DateJuly 31, 2023
Generic Nameapraclonidine hydrochloride ophthalmic solution
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