Ofloxacin
PRESCRIBING INFORMATION Rx Only Ofloxacin Ophthalmic Solution, USP 0.3% STERILE OPHTHALMIC SOLUTION
Approved
Approval ID
cd01954d-918b-456a-e053-2995a90a859c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 17, 2023
Manufacturers
FDA
NuCare Pharmaceuticaals,Inc.
DUNS: 010632300
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 Code68071-2544
Application NumberANDA076513
Product Classification
M
Marketing Category
C73584
G
Generic Name
ofloxacin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 17, 2023
FDA Product Classification
INGREDIENTS (6)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
OFLOXACINActive
Quantity: 3 mg in 1 mL
Code: A4P49JAZ9H
Classification: ACTIB