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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-507
Application NumberANDA210263
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bimatoprost
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 24, 2021
FDA Product Classification
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