Betaxolol
Approved
Approval ID
1fc0a413-4e6b-4ed7-9957-ace4c8cfab55
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 23, 2022
Manufacturers
FDA
Akorn
DUNS: 117696770
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 Code17478-705
Application NumberANDA075386
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betaxolol Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMay 23, 2022
FDA Product Classification
INGREDIENTS (6)
Betaxolol HydrochlorideActive
Quantity: 5 mg in 1 mL
Code: 6X97D2XT0O
Classification: ACTIM
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Benzalkonium ChlorideInactive
Code: F5UM2KM3W7
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT