ofloxacin

Generic: ofloxacin otic

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin otic
Labeler asclemed usa, inc.
Dosage Form SOLUTION
Routes
AURICULAR (OTIC)
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-749
Product ID 76420-749_1aaaf971-7d69-9422-e063-6394a90a2a69
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 76420749
Hyphenated Format 76420-749

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 (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
  • 10 mL in 1 BOTTLE, DROPPER (76420-749-10)
source: ndc

Packages (1)

76420-749-10 10 mL in 1 BOTTLE, DROPPER (76420-749-10)

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": "1aaaf971-7d69-9422-e063-6394a90a2a69", "openfda": {"nui": ["N0000175937", "M0023650"], "unii": ["A4P49JAZ9H"], "rxcui": ["242446"], "spl_set_id": ["ff2abdd2-f7ca-49cd-a2d6-cd2bbd980b0c"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 BOTTLE, DROPPER (76420-749-10)", "package_ndc": "76420-749-10", "marketing_start_date": "20240612"}], "brand_name": "ofloxacin", "product_id": "76420-749_1aaaf971-7d69-9422-e063-6394a90a2a69", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "76420-749", "generic_name": "ofloxacin otic", "labeler_name": "Asclemed USA, Inc.", "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"}