levofloxacin

Generic: levofloxacin

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

levofloxacin 250 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-815
Product ID 76420-815_184fff28-0fd3-da61-e063-6294a90ac035
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201043
Listing Expiration 2026-12-31
Marketing Start 2011-06-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420815
Hyphenated Format 76420-815

Supplemental Identifiers

RxCUI
199884 199885 311296
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 ANDA201043 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (76420-815-00)
  • 5 TABLET, FILM COATED in 1 BOTTLE (76420-815-05)
  • 7 TABLET, FILM COATED in 1 BOTTLE (76420-815-07)
  • 10 TABLET, FILM COATED in 1 BOTTLE (76420-815-10)
  • 14 TABLET, FILM COATED in 1 BOTTLE (76420-815-14)
  • 20 TABLET, FILM COATED in 1 BOTTLE (76420-815-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-815-30)
  • 50 TABLET, FILM COATED in 1 BOTTLE (76420-815-50)
  • 60 TABLET, FILM COATED in 1 BOTTLE (76420-815-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76420-815-90)
source: ndc

Packages (10)

76420-815-00 1000 TABLET, FILM COATED in 1 BOTTLE (76420-815-00) 76420-815-05 5 TABLET, FILM COATED in 1 BOTTLE (76420-815-05) 76420-815-07 7 TABLET, FILM COATED in 1 BOTTLE (76420-815-07) 76420-815-10 10 TABLET, FILM COATED in 1 BOTTLE (76420-815-10) 76420-815-14 14 TABLET, FILM COATED in 1 BOTTLE (76420-815-14) 76420-815-20 20 TABLET, FILM COATED in 1 BOTTLE (76420-815-20) 76420-815-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-815-30) 76420-815-50 50 TABLET, FILM COATED in 1 BOTTLE (76420-815-50) 76420-815-60 60 TABLET, FILM COATED in 1 BOTTLE (76420-815-60) 76420-815-90 90 TABLET, FILM COATED in 1 BOTTLE (76420-815-90)

Ingredients (1)

levofloxacin (250 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": "184fff28-0fd3-da61-e063-6294a90ac035", "openfda": {"nui": ["N0000193223", "M0372253"], "unii": ["6GNT3Y5LMF"], "rxcui": ["199884", "199885", "311296"], "spl_set_id": ["2e32a8aa-047b-46c6-b67b-d88a9a0a810b"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (76420-815-00)", "package_ndc": "76420-815-00", "marketing_start_date": "20240513"}, {"sample": false, "description": "5 TABLET, FILM COATED in 1 BOTTLE (76420-815-05)", "package_ndc": "76420-815-05", "marketing_start_date": "20240513"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE (76420-815-07)", "package_ndc": "76420-815-07", "marketing_start_date": "20240513"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (76420-815-10)", "package_ndc": "76420-815-10", "marketing_start_date": "20240513"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (76420-815-14)", "package_ndc": "76420-815-14", "marketing_start_date": "20240513"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (76420-815-20)", "package_ndc": "76420-815-20", "marketing_start_date": "20240513"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-815-30)", "package_ndc": "76420-815-30", "marketing_start_date": "20240513"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (76420-815-50)", "package_ndc": "76420-815-50", "marketing_start_date": "20240513"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (76420-815-60)", "package_ndc": "76420-815-60", "marketing_start_date": "20240513"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76420-815-90)", "package_ndc": "76420-815-90", "marketing_start_date": "20240513"}], "brand_name": "Levofloxacin", "product_id": "76420-815_184fff28-0fd3-da61-e063-6294a90ac035", "dosage_form": "TABLET, FILM COATED", "product_ndc": "76420-815", "generic_name": "Levofloxacin", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "250 mg/1"}], "application_number": "ANDA201043", "marketing_category": "ANDA", "marketing_start_date": "20110620", "listing_expiration_date": "20261231"}