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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-802
Application NumberANDA205537
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bimatoprost
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 17, 2023
FDA Product Classification
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