ofloxacin

Generic: ofloxacin otic

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

Drug Facts

Product Profile

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

ofloxacin 3 mg/mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-061
Product ID 82804-061_54900137-8062-44cc-9505-3d65dedc8a16
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216130
Listing Expiration 2026-12-31
Marketing Start 2022-07-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804061
Hyphenated Format 82804-061

Supplemental Identifiers

RxCUI
242446
UPC
0382804061051
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 otic (source: ndc)
Application Number ANDA216130 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE, DROPPER (82804-061-05)
source: ndc

Packages (1)

82804-061-05 5 mL in 1 BOTTLE, DROPPER (82804-061-05)

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": "54900137-8062-44cc-9505-3d65dedc8a16", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0382804061051"], "unii": ["A4P49JAZ9H"], "rxcui": ["242446"], "spl_set_id": ["79074efc-83ed-4473-bb86-9f635928ea92"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE, DROPPER (82804-061-05)", "package_ndc": "82804-061-05", "marketing_start_date": "20240101"}], "brand_name": "ofloxacin", "product_id": "82804-061_54900137-8062-44cc-9505-3d65dedc8a16", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "82804-061", "generic_name": "ofloxacin otic", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ofloxacin", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA216130", "marketing_category": "ANDA", "marketing_start_date": "20220715", "listing_expiration_date": "20261231"}