Bimatoprost
These highlights do not include all the information needed to use BIMATOPROST OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BIMATOPROST OPHTHALMIC SOLUTION.BIMATOPROST ophthalmic solution 0.03%, for topical ophthalmic useInitial U.S. Approval: 2001
Approved
Approval ID
2c997c76-fd01-479a-a005-dbdb375560a4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2023
Manufacturers
FDA
Akorn
DUNS: 117696873
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bimatoprost
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50383-912
Application NumberANDA203051
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bimatoprost
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 16, 2022
FDA Product Classification
INGREDIENTS (8)
BIMATOPROSTActive
Quantity: 3 ug in 1 mL
Code: QXS94885MZ
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4B
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT