ofloxacin

Generic: ofloxacin

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin
Labeler leading pharma, llc
Dosage Form SOLUTION
Routes
AURICULAR (OTIC)
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-320
Product ID 69315-320_88154ff7-fd59-4fd3-a82e-e55d3b6192bd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217903
Listing Expiration 2026-12-31
Marketing Start 2024-03-01

Pharmacologic Class

Established (EPC)
quinolone antimicrobial [epc]
Chemical Structure
quinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315320
Hyphenated Format 69315-320

Supplemental Identifiers

RxCUI
242446
UPC
0369315320105 0369315320051
UNII
A4P49JAZ9H
NUI
N0000175937 M0023650

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ofloxacin (source: ndc)
Generic Name ofloxacin (source: ndc)
Application Number ANDA217903 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE, DROPPER (69315-320-05)
  • 10 mL in 1 BOTTLE, DROPPER (69315-320-10)
source: ndc

Packages (2)

69315-320-05 5 mL in 1 BOTTLE, DROPPER (69315-320-05) 69315-320-10 10 mL in 1 BOTTLE, DROPPER (69315-320-10)

Ingredients (1)

ofloxacin (3 mg/mL)

Linked Drug Pages (1)

OFLOXACIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "88154ff7-fd59-4fd3-a82e-e55d3b6192bd", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0369315320105", "0369315320051"], "unii": ["A4P49JAZ9H"], "rxcui": ["242446"], "spl_set_id": ["e43bf505-1030-49cd-a144-19b997fb5575"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE, DROPPER (69315-320-05)", "package_ndc": "69315-320-05", "marketing_start_date": "20240301"}, {"sample": false, "description": "10 mL in 1 BOTTLE, DROPPER (69315-320-10)", "package_ndc": "69315-320-10", "marketing_start_date": "20240301"}], "brand_name": "OFLOXACIN", "product_id": "69315-320_88154ff7-fd59-4fd3-a82e-e55d3b6192bd", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "69315-320", "generic_name": "OFLOXACIN", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OFLOXACIN", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA217903", "marketing_category": "ANDA", "marketing_start_date": "20240301", "listing_expiration_date": "20261231"}