Bepotastine Besilate Ophthalmic Solution 1.5%
These highlights do not include all the information needed to use BEPOTASTINE BESILATE OPHTHALMIC SOLUTION 1.5% safely and effectively. See full prescribing information for BEPOTASTINE BESILATE OPHTHALMIC SOLUTION. BEPOTASTINE Besilate Ophthalmic Solution 1.5% for topical ophthalmic use Initial U.S. Approval: 2009
Approved
Approval ID
de111d74-c740-47b3-adc7-4b855df2c561
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 21, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Limited
DUNS: 650574663
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bepotastine Besilate Ophthalmic Solution 1.5%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-598
Application NumberANDA214588
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bepotastine Besilate Ophthalmic Solution 1.5%
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 21, 2023
FDA Product Classification
INGREDIENTS (6)
BEPOTASTINE BESILATEActive
Quantity: 15 mg in 1 mL
Code: 6W18MO1QR3
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT