Ofloxacin
Ofloxacin Ophthalmic Solution 0.3% (Sterile)
Approved
Approval ID
c8020ad4-ac74-4ceb-863e-94da605cf23f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2022
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ofloxacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63187-268
Application NumberANDA076622
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ofloxacin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateApril 1, 2022
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
OFLOXACINActive
Quantity: 3 mg in 1 mL
Code: A4P49JAZ9H
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT