olfoxacin otic soln

Generic: olfoxacin otic soln

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olfoxacin otic soln
Generic Name olfoxacin otic soln
Labeler direct_rx
Dosage Form SOLUTION
Routes
AURICULAR (OTIC)
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-490
Product ID 72189-490_2c4e3760-8446-4adb-e063-6394a90a5ffc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216130
Listing Expiration 2026-12-31
Marketing Start 2023-06-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189490
Hyphenated Format 72189-490

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 olfoxacin otic soln (source: ndc)
Generic Name olfoxacin otic soln (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 (72189-490-05)
source: ndc

Packages (1)

72189-490-05 5 mL in 1 BOTTLE, DROPPER (72189-490-05)

Ingredients (1)

ofloxacin (3 mg/mL)

Linked Drug Pages (1)

Olfoxacin Otic Soln ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "2c4e3760-8446-4adb-e063-6394a90a5ffc", "openfda": {"nui": ["N0000175937", "M0023650"], "unii": ["A4P49JAZ9H"], "rxcui": ["242446"], "spl_set_id": ["fda35d37-f36a-efc8-e053-6294a90a2bb8"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE, DROPPER (72189-490-05)", "package_ndc": "72189-490-05", "marketing_start_date": "20230608"}], "brand_name": "Olfoxacin Otic Soln", "product_id": "72189-490_2c4e3760-8446-4adb-e063-6394a90a5ffc", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "72189-490", "generic_name": "Olfoxacin Otic Soln", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olfoxacin Otic Soln", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA216130", "marketing_category": "ANDA", "marketing_start_date": "20230608", "listing_expiration_date": "20261231"}