ofloxacin

Generic: ofloxacin

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin
Labeler preferred pharmaceuticals inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8761
Product ID 68788-8761_d359da57-ad0c-4b2d-87bf-70c596c7a371
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076513
Listing Expiration 2027-12-31
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 687888761
Hyphenated Format 68788-8761

Supplemental Identifiers

RxCUI
312075
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 (source: ndc)
Application Number ANDA076513 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (68788-8761-5) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

68788-8761-5 1 BOTTLE, DROPPER in 1 CARTON (68788-8761-5) / 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": ["OPHTHALMIC"], "spl_id": "d359da57-ad0c-4b2d-87bf-70c596c7a371", "openfda": {"nui": ["N0000175937", "M0023650"], "unii": ["A4P49JAZ9H"], "rxcui": ["312075"], "spl_set_id": ["f7916bb3-7593-45f8-b9de-98e0f2d57227"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (68788-8761-5)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "68788-8761-5", "marketing_start_date": "20241111"}], "brand_name": "Ofloxacin", "product_id": "68788-8761_d359da57-ad0c-4b2d-87bf-70c596c7a371", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "68788-8761", "generic_name": "ofloxacin", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ofloxacin", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA076513", "marketing_category": "ANDA", "marketing_start_date": "20241111", "listing_expiration_date": "20271231"}