Brimonidine Tartrate
These highlights do not include all the information needed to use BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION.BRIMONIDINE TARTRATE ophthalmic solution For Topical Ophthalmic UseInitial U.S. Approval: 1996
Approved
Approval ID
7f70f916-b4f9-4552-a002-375df20712cc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 16, 2021
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Brimonidine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-4224
Application NumberANDA076254
Product Classification
M
Marketing Category
C73584
G
Generic Name
Brimonidine Tartrate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMay 16, 2012
FDA Product Classification
INGREDIENTS (9)
BRIMONIDINE TARTRATEActive
Quantity: 2 mg in 1 mL
Code: 4S9CL2DY2H
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT