ofloxacin

Generic: ofloxacin otic

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin otic
Labeler caplin steriles limited
Dosage Form SOLUTION/ DROPS
Routes
AURICULAR (OTIC)
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-143
Product ID 65145-143_47f838f6-cc86-41f5-924a-f6f5c4ddc43e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217903
Listing Expiration 2026-12-31
Marketing Start 2024-12-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65145143
Hyphenated Format 65145-143

Supplemental Identifiers

RxCUI
242446
UPC
0365145143013 0365145144010
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 ANDA217903 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (65145-143-01) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

65145-143-01 1 BOTTLE, DROPPER in 1 CARTON (65145-143-01) / 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": "47f838f6-cc86-41f5-924a-f6f5c4ddc43e", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0365145143013", "0365145144010"], "unii": ["A4P49JAZ9H"], "rxcui": ["242446"], "spl_set_id": ["2bb61a24-87a6-4e74-a319-fc5e7c483bbb"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (65145-143-01)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "65145-143-01", "marketing_start_date": "20241216"}], "brand_name": "Ofloxacin", "product_id": "65145-143_47f838f6-cc86-41f5-924a-f6f5c4ddc43e", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "65145-143", "generic_name": "Ofloxacin Otic", "labeler_name": "Caplin Steriles Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ofloxacin", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA217903", "marketing_category": "ANDA", "marketing_start_date": "20241216", "listing_expiration_date": "20261231"}