ofloxacin

Generic: ofloxacin

Labeler: modavar pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin
Labeler modavar pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ofloxacin 400 mg/1

Manufacturer
Modavar Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72241-074
Product ID 72241-074_5edb8648-37ed-49de-825c-a3d66e5aa4c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091656
Listing Expiration 2027-12-31
Marketing Start 2025-06-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72241074
Hyphenated Format 72241-074

Supplemental Identifiers

RxCUI
198048 198049 198050
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 ANDA091656 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (72241-074-02)
  • 500 TABLET, FILM COATED in 1 BOTTLE (72241-074-05)
  • 50 TABLET, FILM COATED in 1 BOTTLE (72241-074-10)
source: ndc

Packages (3)

Ingredients (1)

ofloxacin (400 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "5edb8648-37ed-49de-825c-a3d66e5aa4c0", "openfda": {"nui": ["N0000175937", "M0023650"], "unii": ["A4P49JAZ9H"], "rxcui": ["198048", "198049", "198050"], "spl_set_id": ["93ed9f70-b44f-496b-bdfc-c1bd5f1c260b"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Modavar Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (72241-074-02)", "package_ndc": "72241-074-02", "marketing_start_date": "20250624"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72241-074-05)", "package_ndc": "72241-074-05", "marketing_start_date": "20250624"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (72241-074-10)", "package_ndc": "72241-074-10", "marketing_start_date": "20250624"}], "brand_name": "OFLOXACIN", "product_id": "72241-074_5edb8648-37ed-49de-825c-a3d66e5aa4c0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "72241-074", "generic_name": "OFLOXACIN", "labeler_name": "Modavar Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OFLOXACIN", "active_ingredients": [{"name": "OFLOXACIN", "strength": "400 mg/1"}], "application_number": "ANDA091656", "marketing_category": "ANDA", "marketing_start_date": "20250624", "listing_expiration_date": "20271231"}