ofloxacin ophth soln

Generic: ofloxacin ophth soln

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin ophth soln
Generic Name ofloxacin ophth soln
Labeler direct_rx
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-472
Product ID 72189-472_2c4e05d7-5de1-f566-e063-6294a90acada
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215886
Listing Expiration 2026-12-31
Marketing Start 2023-05-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189472
Hyphenated Format 72189-472

Supplemental Identifiers

RxCUI
312075
UNII
A4P49JAZ9H
NUI
N0000175937 M0023650

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 ophth soln (source: ndc)
Generic Name ofloxacin ophth soln (source: ndc)
Application Number ANDA215886 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 5 mL in 1 CARTON (72189-472-05)
source: ndc

Packages (1)

72189-472-05 5 mL in 1 CARTON (72189-472-05)

Ingredients (1)

ofloxacin (3 mg/mL)

Linked Drug Pages (1)

Ofloxacin Ophth Soln ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "2c4e05d7-5de1-f566-e063-6294a90acada", "openfda": {"nui": ["N0000175937", "M0023650"], "unii": ["A4P49JAZ9H"], "rxcui": ["312075"], "spl_set_id": ["fc4d4b14-1eeb-0fba-e053-6394a90a738e"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 CARTON (72189-472-05)", "package_ndc": "72189-472-05", "marketing_start_date": "20230522"}], "brand_name": "Ofloxacin Ophth Soln", "product_id": "72189-472_2c4e05d7-5de1-f566-e063-6294a90acada", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "72189-472", "generic_name": "Ofloxacin Ophth Soln", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ofloxacin Ophth Soln", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA215886", "marketing_category": "ANDA", "marketing_start_date": "20230522", "listing_expiration_date": "20261231"}