levofloxacin

Generic: levofloxacin

Labeler: hospira, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler hospira, inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

levofloxacin 500 mg/100mL

Manufacturer
Hospira, Inc

Identifiers & Regulatory

Product NDC 0409-3330
Product ID 0409-3330_3c0a7c98-14cf-4b2e-a4f8-0e6b7b17cd2b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090343
Listing Expiration 2026-12-31
Marketing Start 2024-05-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04093330
Hyphenated Format 0409-3330

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
  • 500 mg/100mL
source: ndc
Packaging
  • 24 POUCH in 1 CARTON (0409-3330-24) / 1 BAG in 1 POUCH (0409-3330-01) / 100 mL in 1 BAG
source: ndc

Packages (1)

0409-3330-24 24 POUCH in 1 CARTON (0409-3330-24) / 1 BAG in 1 POUCH (0409-3330-01) / 100 mL in 1 BAG

Ingredients (1)

levofloxacin (500 mg/100mL)

Linked Drug Pages (1)

Levofloxacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3c0a7c98-14cf-4b2e-a4f8-0e6b7b17cd2b", "openfda": {"nui": ["N0000193223", "M0372253"], "unii": ["6GNT3Y5LMF"], "rxcui": ["1665497", "1665507", "1665515"], "spl_set_id": ["5a1534af-aa1c-4f1d-ba9f-9415b14e1af2"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Hospira, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 POUCH in 1 CARTON (0409-3330-24)  / 1 BAG in 1 POUCH (0409-3330-01)  / 100 mL in 1 BAG", "package_ndc": "0409-3330-24", "marketing_start_date": "20240520"}], "brand_name": "Levofloxacin", "product_id": "0409-3330_3c0a7c98-14cf-4b2e-a4f8-0e6b7b17cd2b", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "0409-3330", "generic_name": "Levofloxacin", "labeler_name": "Hospira, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "500 mg/100mL"}], "application_number": "ANDA090343", "marketing_category": "ANDA", "marketing_start_date": "20240520", "listing_expiration_date": "20261231"}