levofloxacin

Generic: levofloxacin

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levofloxacin 500 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4738
Product ID 68071-4738_2d7d42d7-58d8-aeb9-e063-6294a90ad018
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 680714738
Hyphenated Format 68071-4738

Supplemental Identifiers

RxCUI
199885
UPC
0368071473810
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 (68071-4738-1)
  • 20 TABLET, FILM COATED in 1 BOTTLE (68071-4738-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68071-4738-3)
  • 14 TABLET, FILM COATED in 1 BOTTLE (68071-4738-4)
  • 7 TABLET, FILM COATED in 1 BOTTLE (68071-4738-7)
  • 21 TABLET, FILM COATED in 1 BOTTLE (68071-4738-8)
source: ndc

Packages (6)

68071-4738-1 10 TABLET, FILM COATED in 1 BOTTLE (68071-4738-1) 68071-4738-2 20 TABLET, FILM COATED in 1 BOTTLE (68071-4738-2) 68071-4738-3 30 TABLET, FILM COATED in 1 BOTTLE (68071-4738-3) 68071-4738-4 14 TABLET, FILM COATED in 1 BOTTLE (68071-4738-4) 68071-4738-7 7 TABLET, FILM COATED in 1 BOTTLE (68071-4738-7) 68071-4738-8 21 TABLET, FILM COATED in 1 BOTTLE (68071-4738-8)

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": "2d7d42d7-58d8-aeb9-e063-6294a90ad018", "openfda": {"nui": ["N0000193223", "M0372253"], "upc": ["0368071473810"], "unii": ["6GNT3Y5LMF"], "rxcui": ["199885"], "spl_set_id": ["80501b71-2f08-2ef5-e053-2991aa0a6e86"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (68071-4738-1)", "package_ndc": "68071-4738-1", "marketing_start_date": "20190125"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (68071-4738-2)", "package_ndc": "68071-4738-2", "marketing_start_date": "20190125"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68071-4738-3)", "package_ndc": "68071-4738-3", "marketing_start_date": "20190125"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (68071-4738-4)", "package_ndc": "68071-4738-4", "marketing_start_date": "20190125"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE (68071-4738-7)", "package_ndc": "68071-4738-7", "marketing_start_date": "20190125"}, {"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE (68071-4738-8)", "package_ndc": "68071-4738-8", "marketing_start_date": "20190125"}], "brand_name": "Levofloxacin", "product_id": "68071-4738_2d7d42d7-58d8-aeb9-e063-6294a90ad018", "dosage_form": "TABLET, FILM COATED", "product_ndc": "68071-4738", "generic_name": "Levofloxacin", "labeler_name": "NuCare Pharmaceuticals,Inc.", "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"}