levofloxacin

Generic: levofloxacin

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

Drug Facts

Product Profile

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

levofloxacin 500 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8772
Product ID 68788-8772_6c2423aa-8cfa-481f-97f6-ed4b6f8d0ee6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077652
Listing Expiration 2027-12-31
Marketing Start 2024-11-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888772
Hyphenated Format 68788-8772

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 ANDA077652 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE (68788-8772-1)
  • 20 TABLET, FILM COATED in 1 BOTTLE (68788-8772-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8772-3)
  • 14 TABLET, FILM COATED in 1 BOTTLE (68788-8772-4)
  • 7 TABLET, FILM COATED in 1 BOTTLE (68788-8772-7)
source: ndc

Packages (5)

68788-8772-1 10 TABLET, FILM COATED in 1 BOTTLE (68788-8772-1) 68788-8772-2 20 TABLET, FILM COATED in 1 BOTTLE (68788-8772-2) 68788-8772-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8772-3) 68788-8772-4 14 TABLET, FILM COATED in 1 BOTTLE (68788-8772-4) 68788-8772-7 7 TABLET, FILM COATED in 1 BOTTLE (68788-8772-7)

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": "6c2423aa-8cfa-481f-97f6-ed4b6f8d0ee6", "openfda": {"nui": ["N0000193223", "M0372253"], "unii": ["6GNT3Y5LMF"], "rxcui": ["199885"], "spl_set_id": ["7a12135e-cbad-4fe1-98f7-53c41d1f2a21"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (68788-8772-1)", "package_ndc": "68788-8772-1", "marketing_start_date": "20241120"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (68788-8772-2)", "package_ndc": "68788-8772-2", "marketing_start_date": "20241120"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8772-3)", "package_ndc": "68788-8772-3", "marketing_start_date": "20241120"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (68788-8772-4)", "package_ndc": "68788-8772-4", "marketing_start_date": "20241120"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE (68788-8772-7)", "package_ndc": "68788-8772-7", "marketing_start_date": "20241120"}], "brand_name": "levofloxacin", "product_id": "68788-8772_6c2423aa-8cfa-481f-97f6-ed4b6f8d0ee6", "dosage_form": "TABLET, FILM COATED", "product_ndc": "68788-8772", "generic_name": "levofloxacin", "labeler_name": "Preferred Pharmaceuticals Inc.", "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": "20241120", "listing_expiration_date": "20271231"}