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 use Initial U.S. Approval: 2001
Approved
Approval ID
a4f4ecb2-999f-4656-8f94-2f06c6dd7990
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 25, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
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 Code62332-507
Application NumberANDA210263
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateMarch 24, 2021
Generic NameBimatoprost
INGREDIENTS (7)
BIMATOPROSTActive
Quantity: 0.3 mg in 1 mL
Code: QXS94885MZ
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4B
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT