levofloxacin

Generic: llevofloxacin

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name llevofloxacin
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levofloxacin 750 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0388
Product ID 80425-0388_19afd937-88a9-275c-e063-6294a90aa35c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077652
Listing Expiration 2026-12-31
Marketing Start 2024-05-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250388
Hyphenated Format 80425-0388

Supplemental Identifiers

RxCUI
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 llevofloxacin (source: ndc)
Application Number ANDA077652 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 7 TABLET, FILM COATED in 1 BOTTLE (80425-0388-1)
  • 14 TABLET, FILM COATED in 1 BOTTLE (80425-0388-2)
source: ndc

Packages (2)

80425-0388-1 7 TABLET, FILM COATED in 1 BOTTLE (80425-0388-1) 80425-0388-2 14 TABLET, FILM COATED in 1 BOTTLE (80425-0388-2)

Ingredients (1)

levofloxacin (750 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": "19afd937-88a9-275c-e063-6294a90aa35c", "openfda": {"nui": ["N0000193223", "M0372253"], "unii": ["6GNT3Y5LMF"], "rxcui": ["311296"], "spl_set_id": ["19afbe98-484c-c980-e063-6294a90acdc6"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE (80425-0388-1)", "package_ndc": "80425-0388-1", "marketing_start_date": "20240522"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (80425-0388-2)", "package_ndc": "80425-0388-2", "marketing_start_date": "20240522"}], "brand_name": "Levofloxacin", "product_id": "80425-0388_19afd937-88a9-275c-e063-6294a90aa35c", "dosage_form": "TABLET, FILM COATED", "product_ndc": "80425-0388", "generic_name": "lLevofloxacin", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "750 mg/1"}], "application_number": "ANDA077652", "marketing_category": "ANDA", "marketing_start_date": "20240522", "listing_expiration_date": "20261231"}