bimatoprost

Basic Information

Product Name

bimatoprost

FDA Product Code

57297-429

Regulatory Information

NDC Product Code

57297-429

Application Number

ANDA203991

Marketing Category

C73584

Effective Date

May 4, 2016

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use Bimatoprost Ophthalmic Solution, 0.03% safely and effectively. See full prescribing information for Bimatoprost Ophthalmic Solution, 0.03%. BIMATOPROST Ophthalmic Solution, 0.03% for topical ophthalmic useInitial U.S. Approval: 2001

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

BIMATOPROST

Quantity: 0.3 mg in 1 mL

Code: QXS94885MZ

Class Code: ACTIB

BENZALKONIUM CHLORIDE

Code: F5UM2KM3W7

Class Code: IACT

CITRIC ACID MONOHYDRATE

Code: 2968PHW8QP

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

Code: 70WT22SF4B

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

Code: QXS94885MZ

bimatoprost

Basic Information

Regulatory Information

Company Information

Active Ingredients

BENZALKONIUM CHLORIDE

CITRIC ACID MONOHYDRATE

HYDROCHLORIC ACID

SODIUM CHLORIDE

SODIUM HYDROXIDE

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

WATER

Active Moieties

BIMATOPROST