ofloxacin

Generic: ofloxacin

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

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin
Labeler nucare pharmaceuticals, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3919
Product ID 68071-3919_448425b6-3950-a860-e063-6294a90aa994
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215886
Listing Expiration 2026-12-31
Marketing Start 2023-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713919
Hyphenated Format 68071-3919

Supplemental Identifiers

RxCUI
312075
UPC
0368071391954
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 ANDA215886 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE, DROPPER (68071-3919-5)
source: ndc

Packages (1)

68071-3919-5 5 mL in 1 BOTTLE, DROPPER (68071-3919-5)

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": "448425b6-3950-a860-e063-6294a90aa994", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0368071391954"], "unii": ["A4P49JAZ9H"], "rxcui": ["312075"], "spl_set_id": ["4484283c-7839-e75d-e063-6394a90a8639"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE, DROPPER (68071-3919-5)", "package_ndc": "68071-3919-5", "marketing_start_date": "20251126"}], "brand_name": "ofloxacin", "product_id": "68071-3919_448425b6-3950-a860-e063-6294a90aa994", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "68071-3919", "generic_name": "ofloxacin", "labeler_name": "NuCare Pharmaceuticals, Inc.", "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": "20231201", "listing_expiration_date": "20261231"}