levofloxacin

Generic: levofloxacin

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

levofloxacin 5 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-355
Product ID 63323-355_d2cd980c-648b-4efd-b39d-49c8e0f8f9b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200674
Listing Expiration 2026-12-31
Marketing Start 2013-06-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323355
Hyphenated Format 63323-355

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 ANDA200674 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BAG in 1 POUCH (63323-355-50) / 50 mL in 1 BAG
  • 1 BAG in 1 POUCH (63323-355-60) / 150 mL in 1 BAG
  • 1 BAG in 1 POUCH (63323-355-65) / 100 mL in 1 BAG
source: ndc

Packages (3)

63323-355-50 1 BAG in 1 POUCH (63323-355-50) / 50 mL in 1 BAG 63323-355-60 1 BAG in 1 POUCH (63323-355-60) / 150 mL in 1 BAG 63323-355-65 1 BAG in 1 POUCH (63323-355-65) / 100 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": "d2cd980c-648b-4efd-b39d-49c8e0f8f9b9", "openfda": {"nui": ["N0000193223", "M0372253"], "unii": ["6GNT3Y5LMF"], "rxcui": ["1665497", "1665507", "1665515"], "spl_set_id": ["eb30fafa-bbb9-458f-89df-ae610fa6aa96"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 POUCH (63323-355-50)  / 50 mL in 1 BAG", "package_ndc": "63323-355-50", "marketing_start_date": "20130620"}, {"sample": false, "description": "1 BAG in 1 POUCH (63323-355-60)  / 150 mL in 1 BAG", "package_ndc": "63323-355-60", "marketing_start_date": "20130620"}, {"sample": false, "description": "1 BAG in 1 POUCH (63323-355-65)  / 100 mL in 1 BAG", "package_ndc": "63323-355-65", "marketing_start_date": "20130620"}], "brand_name": "Levofloxacin", "product_id": "63323-355_d2cd980c-648b-4efd-b39d-49c8e0f8f9b9", "dosage_form": "INJECTION", "product_ndc": "63323-355", "generic_name": "LEVOFLOXACIN", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "5 mg/mL"}], "application_number": "ANDA200674", "marketing_category": "ANDA", "marketing_start_date": "20130620", "listing_expiration_date": "20261231"}