Apraclonidine
Apraclonidine Ophthalmic Solution 0.5% as base Rx Only
Approved
Approval ID
04ad82af-e7ba-4f40-a120-be9d33cf0c7b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 25, 2019
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Apraclonidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61314-665
Application NumberNDA020258
Product Classification
M
Marketing Category
C73605
G
Generic Name
Apraclonidine
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 25, 2019
FDA Product Classification
INGREDIENTS (7)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
APRACLONIDINE HYDROCHLORIDEActive
Quantity: 5.75 mg in 1 mL
Code: D2VW67N38H
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT