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 solutionFor Topical Ophthalmic UseInitial U.S. Approval: 1996
Approved
Approval ID
865f88b0-b13e-4607-a314-939f1b331e6f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2022
Manufacturers
FDA
Bausch & Lomb Incorporated
DUNS: 196603781
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 Code24208-411
Application NumberANDA076260
Product Classification
M
Marketing Category
C73584
G
Generic Name
Brimonidine Tartrate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJune 30, 2022
FDA Product Classification
INGREDIENTS (9)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
BRIMONIDINE TARTRATEActive
Quantity: 2 mg in 1 mL
Code: 4S9CL2DY2H
Classification: ACTIB