ofloxacin

Generic: ofloxacin

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin
Labeler proficient rx lp
Dosage Form SOLUTION
Routes
AURICULAR (OTIC)
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-472
Product ID 63187-472_adddd480-d3b1-4497-8bad-b5c55c2bb8bb
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 63187472
Hyphenated Format 63187-472

Supplemental Identifiers

RxCUI
242446
UPC
0363187472054
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 (63187-472-05) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

63187-472-05 1 BOTTLE, DROPPER in 1 CARTON (63187-472-05) / 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": "adddd480-d3b1-4497-8bad-b5c55c2bb8bb", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0363187472054"], "unii": ["A4P49JAZ9H"], "rxcui": ["242446"], "spl_set_id": ["bfe09726-9acb-4032-be91-ef2614662ae2"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (63187-472-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "63187-472-05", "marketing_start_date": "20150202"}], "brand_name": "Ofloxacin", "product_id": "63187-472_adddd480-d3b1-4497-8bad-b5c55c2bb8bb", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "63187-472", "generic_name": "Ofloxacin", "labeler_name": "Proficient Rx LP", "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"}