levofloxacin

Generic: levofloxacin

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

levofloxacin 750 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-533
Product ID 33342-533_fc165a6d-24b0-4753-a7ac-94a134dca0d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200839
Listing Expiration 2026-12-31
Marketing Start 2012-03-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342533
Hyphenated Format 33342-533

Supplemental Identifiers

RxCUI
199884 199885 311296
UPC
0333342533111 0333342531087 0333342532084 0333342533326 0333342531117 0333342532114
UNII
6GNT3Y5LMF
NUI
N0000193223 M0372253

Packaging Origin

Original Packager
true

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 ANDA200839 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (33342-533-11)
  • 100 TABLET, FILM COATED in 1 BLISTER PACK (33342-533-12)
  • 50 TABLET, FILM COATED in 1 BLISTER PACK (33342-533-31)
  • 20 TABLET, FILM COATED in 1 BOTTLE (33342-533-32)
source: ndc

Packages (4)

33342-533-11 100 TABLET, FILM COATED in 1 BOTTLE (33342-533-11) 33342-533-12 100 TABLET, FILM COATED in 1 BLISTER PACK (33342-533-12) 33342-533-31 50 TABLET, FILM COATED in 1 BLISTER PACK (33342-533-31) 33342-533-32 20 TABLET, FILM COATED in 1 BOTTLE (33342-533-32)

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": "fc165a6d-24b0-4753-a7ac-94a134dca0d3", "openfda": {"nui": ["N0000193223", "M0372253"], "upc": ["0333342533111", "0333342531087", "0333342532084", "0333342533326", "0333342531117", "0333342532114"], "unii": ["6GNT3Y5LMF"], "rxcui": ["199884", "199885", "311296"], "spl_set_id": ["fc165a6d-24b0-4753-a7ac-94a134dca0d3"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (33342-533-11)", "package_ndc": "33342-533-11", "marketing_start_date": "20120322"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BLISTER PACK (33342-533-12)", "package_ndc": "33342-533-12", "marketing_start_date": "20120322"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BLISTER PACK (33342-533-31)", "package_ndc": "33342-533-31", "marketing_start_date": "20120322"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (33342-533-32)", "package_ndc": "33342-533-32", "marketing_start_date": "20120322"}], "brand_name": "Levofloxacin", "product_id": "33342-533_fc165a6d-24b0-4753-a7ac-94a134dca0d3", "dosage_form": "TABLET, FILM COATED", "product_ndc": "33342-533", "generic_name": "Levofloxacin", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "750 mg/1"}], "application_number": "ANDA200839", "marketing_category": "ANDA", "marketing_start_date": "20120322", "listing_expiration_date": "20261231"}