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 5 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-0528
Product ID 0409-0528_b9da3d28-6e91-4adc-bed2-27b23eccd8c7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078579
Listing Expiration 2026-12-31
Marketing Start 2017-06-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04090528
Hyphenated Format 0409-0528

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 ANDA078579 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 24 POUCH in 1 CASE (0409-0528-15) / 1 BAG in 1 POUCH / 50 mL in 1 BAG (0409-0528-13)
  • 24 POUCH in 1 CASE (0409-0528-25) / 1 BAG in 1 POUCH / 100 mL in 1 BAG (0409-0528-23)
  • 24 POUCH in 1 CASE (0409-0528-35) / 1 BAG in 1 POUCH / 150 mL in 1 BAG (0409-0528-31)
source: ndc

Packages (3)

0409-0528-15 24 POUCH in 1 CASE (0409-0528-15) / 1 BAG in 1 POUCH / 50 mL in 1 BAG (0409-0528-13) 0409-0528-25 24 POUCH in 1 CASE (0409-0528-25) / 1 BAG in 1 POUCH / 100 mL in 1 BAG (0409-0528-23) 0409-0528-35 24 POUCH in 1 CASE (0409-0528-35) / 1 BAG in 1 POUCH / 150 mL in 1 BAG (0409-0528-31)

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": "b9da3d28-6e91-4adc-bed2-27b23eccd8c7", "openfda": {"nui": ["N0000193223", "M0372253"], "unii": ["6GNT3Y5LMF"], "rxcui": ["1665497", "1665507", "1665515"], "spl_set_id": ["17bcb105-91ff-4240-bba4-29d80001bbe4"], "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 CASE (0409-0528-15)  / 1 BAG in 1 POUCH / 50 mL in 1 BAG (0409-0528-13)", "package_ndc": "0409-0528-15", "marketing_start_date": "20170612"}, {"sample": false, "description": "24 POUCH in 1 CASE (0409-0528-25)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG (0409-0528-23)", "package_ndc": "0409-0528-25", "marketing_start_date": "20170612"}, {"sample": false, "description": "24 POUCH in 1 CASE (0409-0528-35)  / 1 BAG in 1 POUCH / 150 mL in 1 BAG (0409-0528-31)", "package_ndc": "0409-0528-35", "marketing_start_date": "20170612"}], "brand_name": "LEVOFLOXACIN", "product_id": "0409-0528_b9da3d28-6e91-4adc-bed2-27b23eccd8c7", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "0409-0528", "generic_name": "LEVOFLOXACIN", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVOFLOXACIN", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "5 mg/mL"}], "application_number": "ANDA078579", "marketing_category": "ANDA", "marketing_start_date": "20170612", "listing_expiration_date": "20261231"}