ofloxacin otic

Generic: ofloxacin

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin otic
Generic Name ofloxacin
Labeler bryant ranch prepack
Dosage Form SOLUTION
Routes
AURICULAR (OTIC)
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2822
Product ID 71335-2822_ca67210a-78ed-4295-b38b-9fa0cdf85664
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 713352822
Hyphenated Format 71335-2822

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 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 (71335-2822-1)
source: ndc

Packages (1)

71335-2822-1 5 mL in 1 BOTTLE, DROPPER (71335-2822-1)

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": "ca67210a-78ed-4295-b38b-9fa0cdf85664", "openfda": {"nui": ["N0000175937", "M0023650"], "unii": ["A4P49JAZ9H"], "rxcui": ["242446"], "spl_set_id": ["7ba2d774-27d8-4ee0-9ef3-cc4900dcc5fa"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE, DROPPER (71335-2822-1)", "package_ndc": "71335-2822-1", "marketing_start_date": "20251030"}], "brand_name": "Ofloxacin Otic", "product_id": "71335-2822_ca67210a-78ed-4295-b38b-9fa0cdf85664", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "71335-2822", "generic_name": "Ofloxacin", "labeler_name": "Bryant Ranch Prepack", "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"}