Brimonidine Tartrate

Manufacturing Establishments1

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

Labeler

Indoco Remedies Limited

DUNS Number

915851870

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

NDC Product Code

14445-400

Application Number

ANDA091691

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

December 27, 2018

Ingredients

Sodium CitrateInactive

Code: 1Q73Q2JULRClass: IACT

WaterInactive

Code: 059QF0KO0RClass: IACT

Benzalkonium ChlorideInactive

Code: F5UM2KM3W7Class: IACT

Sodium ChlorideInactive

Code: 451W47IQ8XClass: IACT

Citric Acid MonohydrateInactive

Code: 2968PHW8QPClass: IACT

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

Polyvinyl AlcoholInactive

Code: 532B59J990Class: IACT

Hydrochloric acidInactive

Code: QTT17582CBClass: IACT

Sodium hydroxideInactive

Code: 55X04QC32IClass: IACT