levofloxacin

Generic: levofloxacin

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler coupler llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levofloxacin 250 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1078
Product ID 67046-1078_2cee69f0-e493-7eb5-e063-6394a90a4b99
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077652
Listing Expiration 2026-12-31
Marketing Start 2025-01-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461078
Hyphenated Format 67046-1078

Supplemental Identifiers

RxCUI
199884
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 ANDA077652 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1078-3)
source: ndc

Packages (1)

67046-1078-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1078-3)

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": "2cee69f0-e493-7eb5-e063-6394a90a4b99", "openfda": {"nui": ["N0000193223", "M0372253"], "unii": ["6GNT3Y5LMF"], "rxcui": ["199884"], "spl_set_id": ["2cee61b7-be51-0fe5-e063-6294a90af9e3"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1078-3)", "package_ndc": "67046-1078-3", "marketing_start_date": "20250130"}], "brand_name": "levofloxacin", "product_id": "67046-1078_2cee69f0-e493-7eb5-e063-6394a90a4b99", "dosage_form": "TABLET, FILM COATED", "product_ndc": "67046-1078", "generic_name": "levofloxacin", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "250 mg/1"}], "application_number": "ANDA077652", "marketing_category": "ANDA", "marketing_start_date": "20250130", "listing_expiration_date": "20261231"}