BEPREVE
These highlights do not include all the information needed to use BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5% safely and effectively. See full prescribing information for BEPREVE™.BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5%Initial U.S. Approval: 2009
Approved
Approval ID
7c77517f-24c7-4778-94a7-873d11c3c657
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
bepotastine besilate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6299
Application NumberNDA022288
Product Classification
M
Marketing Category
C73594
G
Generic Name
bepotastine besilate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 3, 2011
FDA Product Classification
INGREDIENTS (6)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956
Classification: IACT
BEPOTASTINEActive
Quantity: 15 mg in 1 mL
Code: HYD2U48IAS
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT