ofloxacin

Generic: ofloxacin

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin
Labeler major pharmaceuticals
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7434
Product ID 0904-7434_53a8315c-ae56-4ea0-bdab-ac0d8590d628
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215886
Listing Expiration 2026-12-31
Marketing Start 2024-11-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047434
Hyphenated Format 0904-7434

Supplemental Identifiers

RxCUI
312075
UPC
0309047434053 0309047434107
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 (source: ndc)
Application Number ANDA215886 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (0904-7434-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0904-7434-10) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

0904-7434-05 1 BOTTLE, DROPPER in 1 CARTON (0904-7434-05) / 5 mL in 1 BOTTLE, DROPPER 0904-7434-10 1 BOTTLE, DROPPER in 1 CARTON (0904-7434-10) / 10 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": ["OPHTHALMIC"], "spl_id": "53a8315c-ae56-4ea0-bdab-ac0d8590d628", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0309047434053", "0309047434107"], "unii": ["A4P49JAZ9H"], "rxcui": ["312075"], "spl_set_id": ["2d7a1f80-1c59-49e6-aff7-aedacade2dd6"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0904-7434-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0904-7434-05", "marketing_start_date": "20241111"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0904-7434-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "0904-7434-10", "marketing_start_date": "20241111"}], "brand_name": "ofloxacin", "product_id": "0904-7434_53a8315c-ae56-4ea0-bdab-ac0d8590d628", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "0904-7434", "generic_name": "ofloxacin", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ofloxacin", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA215886", "marketing_category": "ANDA", "marketing_start_date": "20241111", "listing_expiration_date": "20261231"}