ofloxacin otic

Generic: ofloxacin

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

Drug Facts

Product Profile

Brand Name ofloxacin otic
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 63187-184
Product ID 63187-184_494bc1d0-100f-46c4-b35f-8248fc20b727
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076527
Listing Expiration 2026-12-31
Marketing Start 2004-05-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187184
Hyphenated Format 63187-184

Supplemental Identifiers

RxCUI
242446
UPC
0363187184056
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 otic (source: ndc)
Generic Name ofloxacin (source: ndc)
Application Number ANDA076527 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE, DROPPER (63187-184-05)
source: ndc

Packages (1)

63187-184-05 5 mL in 1 BOTTLE, DROPPER (63187-184-05)

Ingredients (1)

ofloxacin (3 mg/mL)

Linked Drug Pages (1)

Ofloxacin Otic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "494bc1d0-100f-46c4-b35f-8248fc20b727", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0363187184056"], "unii": ["A4P49JAZ9H"], "rxcui": ["242446"], "spl_set_id": ["14e6e355-3a87-43dc-80a2-070b9df93bf1"], "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 (63187-184-05)", "package_ndc": "63187-184-05", "marketing_start_date": "20190101"}], "brand_name": "Ofloxacin Otic", "product_id": "63187-184_494bc1d0-100f-46c4-b35f-8248fc20b727", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "63187-184", "generic_name": "Ofloxacin", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ofloxacin Otic", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA076527", "marketing_category": "ANDA", "marketing_start_date": "20040514", "listing_expiration_date": "20261231"}