ofloxacin otic

Generic: ofloxacin

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

Drug Facts

Product Profile

Brand Name ofloxacin otic
Generic Name ofloxacin
Labeler apotex corp.
Dosage Form SOLUTION
Routes
AURICULAR (OTIC)
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-0363
Product ID 60505-0363_b1c42fcf-f4c3-117c-4fa2-7a68c821acd7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076527
Listing Expiration 2026-12-31
Marketing Start 2004-05-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605050363
Hyphenated Format 60505-0363

Supplemental Identifiers

RxCUI
242446
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 otic (source: ndc)
Generic Name ofloxacin (source: ndc)
Application Number ANDA076527 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE, DROPPER (60505-0363-1)
  • 10 mL in 1 BOTTLE, DROPPER (60505-0363-2)
source: ndc

Packages (2)

60505-0363-1 5 mL in 1 BOTTLE, DROPPER (60505-0363-1) 60505-0363-2 10 mL in 1 BOTTLE, DROPPER (60505-0363-2)

Ingredients (1)

ofloxacin (3 mg/mL)

Linked Drug Pages (1)

Ofloxacin Otic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "b1c42fcf-f4c3-117c-4fa2-7a68c821acd7", "openfda": {"nui": ["N0000175937", "M0023650"], "unii": ["A4P49JAZ9H"], "rxcui": ["242446"], "spl_set_id": ["8db221b1-32f3-f6ca-e404-71f56a860d08"], "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": "5 mL in 1 BOTTLE, DROPPER (60505-0363-1)", "package_ndc": "60505-0363-1", "marketing_start_date": "20040514"}, {"sample": false, "description": "10 mL in 1 BOTTLE, DROPPER (60505-0363-2)", "package_ndc": "60505-0363-2", "marketing_start_date": "20040514"}], "brand_name": "Ofloxacin Otic", "product_id": "60505-0363_b1c42fcf-f4c3-117c-4fa2-7a68c821acd7", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "60505-0363", "generic_name": "Ofloxacin", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ofloxacin Otic", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA076527", "marketing_category": "ANDA", "marketing_start_date": "20040514", "listing_expiration_date": "20261231"}