ofloxacin

Generic: ofloxacin

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin
Labeler apotex corp.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-0560
Product ID 60505-0560_9fc163d2-e518-3e95-f589-2ad375775998
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076513
Listing Expiration 2026-12-31
Marketing Start 2019-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605050560
Hyphenated Format 60505-0560

Supplemental Identifiers

RxCUI
312075
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 ANDA076513 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (60505-0560-0) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (60505-0560-1) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

60505-0560-0 1 BOTTLE, DROPPER in 1 CARTON (60505-0560-0) / 5 mL in 1 BOTTLE, DROPPER 60505-0560-1 1 BOTTLE, DROPPER in 1 CARTON (60505-0560-1) / 10 mL in 1 BOTTLE, DROPPER

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": ["OPHTHALMIC"], "spl_id": "9fc163d2-e518-3e95-f589-2ad375775998", "openfda": {"nui": ["N0000175937", "M0023650"], "unii": ["A4P49JAZ9H"], "rxcui": ["312075"], "spl_set_id": ["5117d567-2004-c5ed-1391-f8831864696f"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60505-0560-0)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "60505-0560-0", "marketing_start_date": "20190301"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60505-0560-1)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "60505-0560-1", "marketing_start_date": "20190301"}], "brand_name": "Ofloxacin", "product_id": "60505-0560_9fc163d2-e518-3e95-f589-2ad375775998", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "60505-0560", "generic_name": "ofloxacin", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ofloxacin", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA076513", "marketing_category": "ANDA", "marketing_start_date": "20190301", "listing_expiration_date": "20261231"}