levofloxacin

Generic: levofloxacin in 5% dextrose

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin in 5% dextrose
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

levofloxacin 250 mg/50mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-243
Product ID 55150-243_8cb7f273-fc11-48e7-b2ef-a5290ab7ac4e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206919
Listing Expiration 2026-12-31
Marketing Start 2016-02-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150243
Hyphenated Format 55150-243

Supplemental Identifiers

RxCUI
1665497 1665507 1665515
UPC
0355150244478
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 in 5% dextrose (source: ndc)
Application Number ANDA206919 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 250 mg/50mL
source: ndc
Packaging
  • 24 POUCH in 1 CARTON (55150-243-46) / 1 BAG in 1 POUCH / 50 mL in 1 BAG
source: ndc

Packages (1)

55150-243-46 24 POUCH in 1 CARTON (55150-243-46) / 1 BAG in 1 POUCH / 50 mL in 1 BAG

Ingredients (1)

levofloxacin (250 mg/50mL)

Linked Drug Pages (1)

Levofloxacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "8cb7f273-fc11-48e7-b2ef-a5290ab7ac4e", "openfda": {"nui": ["N0000193223", "M0372253"], "upc": ["0355150244478"], "unii": ["6GNT3Y5LMF"], "rxcui": ["1665497", "1665507", "1665515"], "spl_set_id": ["7d3f83bf-2db7-4657-9538-406adf321ad5"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 POUCH in 1 CARTON (55150-243-46)  / 1 BAG in 1 POUCH / 50 mL in 1 BAG", "package_ndc": "55150-243-46", "marketing_start_date": "20160210"}], "brand_name": "Levofloxacin", "product_id": "55150-243_8cb7f273-fc11-48e7-b2ef-a5290ab7ac4e", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "55150-243", "generic_name": "Levofloxacin in 5% Dextrose", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "250 mg/50mL"}], "application_number": "ANDA206919", "marketing_category": "ANDA", "marketing_start_date": "20160210", "listing_expiration_date": "20261231"}