Brimonidine Tartrate

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Physicians Total Care, Inc.

DUNS Number

194123980

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

54868-6287

Application Number

ANDA076260

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

February 19, 2013

Ingredients

BENZALKONIUM CHLORIDEInactive

Code: F5UM2KM3W7Class: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

Code: 4S9CL2DY2HClass: ACTIBQuantity: 2 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990Class: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

SODIUM CITRATEInactive

Code: 1Q73Q2JULRClass: IACT