levofloxacin

Generic: levofloxacin

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

levofloxacin 500 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 65841-692
Product ID 65841-692_5aeae448-e53f-4954-9dd9-2bcc3dd791d4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077652
Listing Expiration 2026-12-31
Marketing Start 2010-11-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65841692
Hyphenated Format 65841-692

Supplemental Identifiers

RxCUI
199884 199885 311296
UPC
0372578100063
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 ANDA077652 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65841-692-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65841-692-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65841-692-10)
  • 50 TABLET, FILM COATED in 1 BOTTLE (65841-692-18)
source: ndc

Packages (4)

65841-692-01 100 TABLET, FILM COATED in 1 BOTTLE (65841-692-01) 65841-692-05 500 TABLET, FILM COATED in 1 BOTTLE (65841-692-05) 65841-692-10 1000 TABLET, FILM COATED in 1 BOTTLE (65841-692-10) 65841-692-18 50 TABLET, FILM COATED in 1 BOTTLE (65841-692-18)

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": "5aeae448-e53f-4954-9dd9-2bcc3dd791d4", "openfda": {"nui": ["N0000193223", "M0372253"], "upc": ["0372578100063"], "unii": ["6GNT3Y5LMF"], "rxcui": ["199884", "199885", "311296"], "spl_set_id": ["ffa121b8-388f-4d7b-af48-d4aa8d9b5961"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65841-692-01)", "package_ndc": "65841-692-01", "marketing_start_date": "20121110"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65841-692-05)", "package_ndc": "65841-692-05", "marketing_start_date": "20121110"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65841-692-10)", "package_ndc": "65841-692-10", "marketing_start_date": "20121110"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (65841-692-18)", "package_ndc": "65841-692-18", "marketing_start_date": "20121110"}], "brand_name": "levofloxacin", "product_id": "65841-692_5aeae448-e53f-4954-9dd9-2bcc3dd791d4", "dosage_form": "TABLET, FILM COATED", "product_ndc": "65841-692", "generic_name": "levofloxacin", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "500 mg/1"}], "application_number": "ANDA077652", "marketing_category": "ANDA", "marketing_start_date": "20101110", "listing_expiration_date": "20261231"}