levofloxacin

Generic: levofloxacin

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levofloxacin 500 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-3314
Product ID 50090-3314_2f6dbdc6-0b16-47c9-b256-187724d65533
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202801
Listing Expiration 2026-12-31
Marketing Start 2015-01-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500903314
Hyphenated Format 50090-3314

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 ANDA202801 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE (50090-3314-0)
  • 7 TABLET, FILM COATED in 1 BOTTLE (50090-3314-1)
source: ndc

Packages (2)

50090-3314-0 10 TABLET, FILM COATED in 1 BOTTLE (50090-3314-0) 50090-3314-1 7 TABLET, FILM COATED in 1 BOTTLE (50090-3314-1)

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": "2f6dbdc6-0b16-47c9-b256-187724d65533", "openfda": {"nui": ["N0000193223", "M0372253"], "unii": ["6GNT3Y5LMF"], "rxcui": ["199885"], "spl_set_id": ["bdc8b2cc-a914-4613-ac7c-e8dfe91dea13"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (50090-3314-0)", "package_ndc": "50090-3314-0", "marketing_start_date": "20171228"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE (50090-3314-1)", "package_ndc": "50090-3314-1", "marketing_start_date": "20231030"}], "brand_name": "Levofloxacin", "product_id": "50090-3314_2f6dbdc6-0b16-47c9-b256-187724d65533", "dosage_form": "TABLET, FILM COATED", "product_ndc": "50090-3314", "generic_name": "Levofloxacin", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "500 mg/1"}], "application_number": "ANDA202801", "marketing_category": "ANDA", "marketing_start_date": "20150109", "listing_expiration_date": "20261231"}