levofloxacin

Generic: levofloxacin

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

Drug Facts

Product Profile

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

levofloxacin 500 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0008
Product ID 80425-0008_2a981e22-d7c9-311b-e063-6294a90ab25f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201043
Listing Expiration 2026-12-31
Marketing Start 2011-06-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250008
Hyphenated Format 80425-0008

Supplemental Identifiers

RxCUI
199885
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 ANDA201043 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 14 TABLET, FILM COATED in 1 BOTTLE (80425-0008-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (80425-0008-2)
source: ndc

Packages (2)

80425-0008-1 14 TABLET, FILM COATED in 1 BOTTLE (80425-0008-1) 80425-0008-2 30 TABLET, FILM COATED in 1 BOTTLE (80425-0008-2)

Ingredients (1)

levofloxacin (500 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": "2a981e22-d7c9-311b-e063-6294a90ab25f", "openfda": {"nui": ["N0000193223", "M0372253"], "unii": ["6GNT3Y5LMF"], "rxcui": ["199885"], "spl_set_id": ["afd5cb35-4232-f8b1-e053-2a95a90a8c5b"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (80425-0008-1)", "package_ndc": "80425-0008-1", "marketing_start_date": "20110620"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0008-2)", "package_ndc": "80425-0008-2", "marketing_start_date": "20110620"}], "brand_name": "Levofloxacin", "product_id": "80425-0008_2a981e22-d7c9-311b-e063-6294a90ab25f", "dosage_form": "TABLET, FILM COATED", "product_ndc": "80425-0008", "generic_name": "Levofloxacin", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "500 mg/1"}], "application_number": "ANDA201043", "marketing_category": "ANDA", "marketing_start_date": "20110620", "listing_expiration_date": "20261231"}