levofloxacin

Generic: levofloxacin

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

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levofloxacin 250 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6351
Product ID 0904-6351_7b6b4ee0-79a7-477b-bdc7-94111cc34ddb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076710
Listing Expiration 2026-12-31
Marketing Start 2013-12-01

Pharmacologic Class

Established (EPC)
fluoroquinolone antibacterial [epc]
Chemical Structure
fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046351
Hyphenated Format 0904-6351

Supplemental Identifiers

RxCUI
199884 199885 311296
UNII
6GNT3Y5LMF
NUI
N0000193223 M0372253

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 levofloxacin (source: ndc)
Generic Name levofloxacin (source: ndc)
Application Number ANDA076710 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-6351-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6351-61 100 BLISTER PACK in 1 CARTON (0904-6351-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

levofloxacin (250 mg/1)

Linked Drug Pages (1)

Levofloxacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7b6b4ee0-79a7-477b-bdc7-94111cc34ddb", "openfda": {"nui": ["N0000193223", "M0372253"], "unii": ["6GNT3Y5LMF"], "rxcui": ["199884", "199885", "311296"], "spl_set_id": ["ac4001ca-882f-4d9b-a570-c1b9d7fd6830"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6351-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6351-61", "marketing_start_date": "20131201"}], "brand_name": "Levofloxacin", "product_id": "0904-6351_7b6b4ee0-79a7-477b-bdc7-94111cc34ddb", "dosage_form": "TABLET, FILM COATED", "product_ndc": "0904-6351", "generic_name": "Levofloxacin", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "250 mg/1"}], "application_number": "ANDA076710", "marketing_category": "ANDA", "marketing_start_date": "20131201", "listing_expiration_date": "20261231"}