Brinzolamide (Page 3 of 3)

PRINCIPAL DISPLAY PANEL

NDC 0591-2127-79

Brinzolamide Ophthalmic Suspension, USP
1%

For Topical Ophthalmic Use Only

Rx only

10 mL

1
(click image for full-size original)
BRINZOLAMIDE
brinzolamide suspension/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2127
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BRINZOLAMIDE (BRINZOLAMIDE) BRINZOLAMIDE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
EDETATE DISODIUM
MANNITOL
SODIUM CHLORIDE
TYLOXAPOL
WATER
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-2127-79 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 10 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0591-2127-79)
2 NDC:0591-2127-12 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
2 15 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0591-2127-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209406 03/08/2021
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 09/2020 Actavis Pharma, Inc.

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