Betaxolol Hydrochloride
Betaxolol Hydrochloride Ophthalmic Solution, 0.5% as base Sterile Rx Only
Approved
Approval ID
a73519d5-546c-4377-92ed-0d4be2685d60
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Betaxolol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61314-245
Application NumberNDA019270
Product Classification
M
Marketing Category
C73605
G
Generic Name
Betaxolol Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (7)
BETAXOLOL HYDROCHLORIDEActive
Quantity: 5.6 mg in 1 mL
Code: 6X97D2XT0O
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT