Bimatoprost
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 use Initial U.S. Approval: 2001
Approved
Approval ID
059a60ec-aee2-4c13-8307-05cd92e8729a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 17, 2023
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bimatoprost
PRODUCT DETAILS
NDC Product Code65862-802
Application NumberANDA205537
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateJuly 17, 2023
Generic NameBimatoprost
INGREDIENTS (8)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4B
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BIMATOPROSTActive
Quantity: 0.3 mg in 1 mL
Code: QXS94885MZ
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT