Apraclonidine Ophthalmic
Apraclonidine Ophthalmic Solution, USP0.5% as base
Approved
Approval ID
dc7d3a9f-c0b9-411c-9c62-0a14f1718b00
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2022
Manufacturers
FDA
Akorn
DUNS: 117693100
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Apraclonidine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17478-716
Application NumberANDA077764
Product Classification
M
Marketing Category
C73584
G
Generic Name
Apraclonidine Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateFebruary 1, 2009
FDA Product Classification
INGREDIENTS (6)
benzalkonium chlorideInactive
Code: F5UM2KM3W7
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
apraclonidine hydrochlorideActive
Quantity: 5 mg in 1 mL
Code: D2VW67N38H
Classification: ACTIM
sodium acetateInactive
Code: 4550K0SC9B
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT