Brimonidine Tartrate
Approved
Approval ID
bc1785c5-1448-4791-9868-2fbbc8703b3b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6094
Application NumberNDA021764
Product Classification
M
Marketing Category
C73594
G
Generic Name
brimonidine tartrate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 12, 2010
FDA Product Classification
INGREDIENTS (12)
BRIMONIDINE TARTRATEActive
Quantity: 1.5 mg in 1 mL
Code: 4S9CL2DY2H
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QO
Classification: IACT
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5M
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9O
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT