levofloxacin

Generic: levofloxacin

Labeler: wg critical care, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler wg critical care, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

levofloxacin 5 mg/mL

Manufacturer
WG Critical Care, LLC

Identifiers & Regulatory

Product NDC 44567-435
Product ID 44567-435_e6bfbccc-f54c-4d4d-b268-b4fc803e372b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090343
Listing Expiration 2026-12-31
Marketing Start 2016-04-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 44567435
Hyphenated Format 44567-435

Supplemental Identifiers

RxCUI
1665497 1665507 1665515
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 ANDA090343 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 24 POUCH in 1 CARTON (44567-435-24) / 1 BAG in 1 POUCH / 50 mL in 1 BAG
source: ndc

Packages (1)

44567-435-24 24 POUCH in 1 CARTON (44567-435-24) / 1 BAG in 1 POUCH / 50 mL in 1 BAG

Ingredients (1)

levofloxacin (5 mg/mL)

Linked Drug Pages (1)

Levofloxacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e6bfbccc-f54c-4d4d-b268-b4fc803e372b", "openfda": {"nui": ["N0000193223", "M0372253"], "unii": ["6GNT3Y5LMF"], "rxcui": ["1665497", "1665507", "1665515"], "spl_set_id": ["9020cdeb-65fe-458f-bbbd-69265a49906e"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["WG Critical Care, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 POUCH in 1 CARTON (44567-435-24)  / 1 BAG in 1 POUCH / 50 mL in 1 BAG", "package_ndc": "44567-435-24", "marketing_start_date": "20160414"}], "brand_name": "Levofloxacin", "product_id": "44567-435_e6bfbccc-f54c-4d4d-b268-b4fc803e372b", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "44567-435", "generic_name": "Levofloxacin", "labeler_name": "WG Critical Care, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "5 mg/mL"}], "application_number": "ANDA090343", "marketing_category": "ANDA", "marketing_start_date": "20160414", "listing_expiration_date": "20261231"}