ofloxacin

Generic: ofloxacin ophthalmic solution usp, 0.3%

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin ophthalmic solution usp, 0.3%
Labeler caplin steriles limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-142
Product ID 65145-142_b7001e6b-0d32-4256-8352-058bc49b9782
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217904
Listing Expiration 2026-12-31
Marketing Start 2025-02-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65145142
Hyphenated Format 65145-142

Supplemental Identifiers

RxCUI
312075
UPC
0365145142016 0365145141019
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 ophthalmic solution usp, 0.3% (source: ndc)
Application Number ANDA217904 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 10 mL in 1 BOTTLE, DROPPER (65145-142-01)
source: ndc

Packages (1)

65145-142-01 10 mL in 1 BOTTLE, DROPPER (65145-142-01)

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": "b7001e6b-0d32-4256-8352-058bc49b9782", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0365145142016", "0365145141019"], "unii": ["A4P49JAZ9H"], "rxcui": ["312075"], "spl_set_id": ["53f7ec2e-5b4c-4f8c-b8ba-7f8844e0c01b"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 BOTTLE, DROPPER (65145-142-01)", "package_ndc": "65145-142-01", "marketing_start_date": "20250205"}], "brand_name": "Ofloxacin", "product_id": "65145-142_b7001e6b-0d32-4256-8352-058bc49b9782", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "65145-142", "generic_name": "Ofloxacin Ophthalmic Solution USP, 0.3%", "labeler_name": "Caplin Steriles Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ofloxacin", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA217904", "marketing_category": "ANDA", "marketing_start_date": "20250205", "listing_expiration_date": "20261231"}