ofloxacin

Generic: ofloxacin

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin
Labeler somerset therapeutics, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-411
Product ID 70069-411_d83e31c5-0a6d-49d6-afd8-34d0c406a401
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213597
Listing Expiration 2026-12-31
Marketing Start 2024-10-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069411
Hyphenated Format 70069-411

Supplemental Identifiers

RxCUI
312075
UPC
0370069411018
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 ANDA213597 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70069-411-01) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

70069-411-01 1 BOTTLE in 1 CARTON (70069-411-01) / 5 mL in 1 BOTTLE

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": "d83e31c5-0a6d-49d6-afd8-34d0c406a401", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0370069411018"], "unii": ["A4P49JAZ9H"], "rxcui": ["312075"], "spl_set_id": ["4b2b893d-c19b-4c4a-85de-ff901325080b"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70069-411-01)  / 5 mL in 1 BOTTLE", "package_ndc": "70069-411-01", "marketing_start_date": "20241010"}], "brand_name": "Ofloxacin", "product_id": "70069-411_d83e31c5-0a6d-49d6-afd8-34d0c406a401", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "70069-411", "generic_name": "Ofloxacin", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ofloxacin", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA213597", "marketing_category": "ANDA", "marketing_start_date": "20241010", "listing_expiration_date": "20261231"}