MedPath

Ofloxacin

Approved
Approval ID

fcd7c5d7-42f4-4dcb-bc84-d976fafd5df4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 3, 2022

Manufacturers
FDA

MWI

DUNS: 019926120

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 Code13985-602
Application NumberANDA076407
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ofloxacin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 27, 2015
FDA Product Classification

INGREDIENTS (6)

Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
OfloxacinActive
Quantity: 3 mg in 1 mL
Code: A4P49JAZ9H
Classification: ACTIB
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Benzalkonium ChlorideInactive
Code: F5UM2KM3W7
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT

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Ofloxacin - FDA Drug Approval Details