ofloxacin

Generic: ofloxacin

Labeler: redpharm drug
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin
Labeler redpharm drug
Dosage Form SOLUTION
Routes
AURICULAR (OTIC)
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
Redpharm Drug

Identifiers & Regulatory

Product NDC 67296-1925
Product ID 67296-1925_4727d005-5aef-1d14-e063-6294a90a04e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076128
Listing Expiration 2026-12-31
Marketing Start 2008-03-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 672961925
Hyphenated Format 67296-1925

Supplemental Identifiers

RxCUI
242446
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 (source: ndc)
Generic Name ofloxacin (source: ndc)
Application Number ANDA076128 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (67296-1925-1) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

67296-1925-1 1 BOTTLE, DROPPER in 1 CARTON (67296-1925-1) / 5 mL in 1 BOTTLE, DROPPER

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": ["AURICULAR (OTIC)"], "spl_id": "4727d005-5aef-1d14-e063-6294a90a04e5", "openfda": {"nui": ["N0000175937", "M0023650"], "unii": ["A4P49JAZ9H"], "rxcui": ["242446"], "spl_set_id": ["2fbd51a5-462c-4741-e063-6394a90a0d87"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Redpharm Drug"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (67296-1925-1)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "67296-1925-1", "marketing_start_date": "20080317"}], "brand_name": "Ofloxacin", "product_id": "67296-1925_4727d005-5aef-1d14-e063-6294a90a04e5", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "67296-1925", "generic_name": "Ofloxacin", "labeler_name": "Redpharm Drug", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ofloxacin", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA076128", "marketing_category": "ANDA", "marketing_start_date": "20080317", "listing_expiration_date": "20261231"}