ofloxacin ophthalmic

Generic: ofloxacin

Labeler: altaire pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin ophthalmic
Generic Name ofloxacin
Labeler altaire pharmaceuticals inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
Altaire Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59390-140
Product ID 59390-140_28125c1a-d1b0-4763-9b5e-07b4cfc2d889
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202692
Listing Expiration 2026-12-31
Marketing Start 2013-05-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59390140
Hyphenated Format 59390-140

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 ophthalmic (source: ndc)
Generic Name ofloxacin (source: ndc)
Application Number ANDA202692 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE, DROPPER (59390-140-05)
source: ndc

Packages (1)

59390-140-05 5 mL in 1 BOTTLE, DROPPER (59390-140-05)

Ingredients (1)

ofloxacin (3 mg/mL)

Linked Drug Pages (1)

Ofloxacin ophthalmic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "28125c1a-d1b0-4763-9b5e-07b4cfc2d889", "openfda": {"nui": ["N0000175937", "M0023650"], "unii": ["A4P49JAZ9H"], "rxcui": ["312075"], "spl_set_id": ["fe564e33-8f5d-4b57-87a9-7afae02eaf97"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Altaire Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE, DROPPER (59390-140-05)", "package_ndc": "59390-140-05", "marketing_start_date": "20130531"}], "brand_name": "Ofloxacin ophthalmic", "product_id": "59390-140_28125c1a-d1b0-4763-9b5e-07b4cfc2d889", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "59390-140", "generic_name": "Ofloxacin", "labeler_name": "Altaire Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ofloxacin ophthalmic", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA202692", "marketing_category": "ANDA", "marketing_start_date": "20130531", "listing_expiration_date": "20261231"}