ofloxacin

Generic: ofloxacin otic

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin otic
Labeler amneal pharmaceuticals ny llc
Dosage Form SOLUTION
Routes
AURICULAR (OTIC)
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1615
Product ID 69238-1615_d15f384c-ca53-4e8c-8d50-bfa1eef73abb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211525
Listing Expiration 2026-12-31
Marketing Start 2020-03-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692381615
Hyphenated Format 69238-1615

Supplemental Identifiers

RxCUI
242446
UNII
A4P49JAZ9H
NUI
N0000175937 M0023650

Packaging Origin

Original Packager
true

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 ANDA211525 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (69238-1615-3) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

69238-1615-3 1 BOTTLE, DROPPER in 1 CARTON (69238-1615-3) / 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": "d15f384c-ca53-4e8c-8d50-bfa1eef73abb", "openfda": {"nui": ["N0000175937", "M0023650"], "unii": ["A4P49JAZ9H"], "rxcui": ["242446"], "spl_set_id": ["ba37e2a0-1bf7-41ca-bddd-35fcb77f87de"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (69238-1615-3)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "69238-1615-3", "marketing_start_date": "20200317"}], "brand_name": "Ofloxacin", "product_id": "69238-1615_d15f384c-ca53-4e8c-8d50-bfa1eef73abb", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "69238-1615", "generic_name": "Ofloxacin Otic", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ofloxacin", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA211525", "marketing_category": "ANDA", "marketing_start_date": "20200317", "listing_expiration_date": "20261231"}