levofloxacin

Generic: levofloxacin

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

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

levofloxacin 500 mg/20mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-156
Product ID 55150-156_2a91fee4-6952-42e2-8326-c2d4233d11d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202328
Listing Expiration 2026-12-31
Marketing Start 2013-01-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150156
Hyphenated Format 55150-156

Supplemental Identifiers

RxCUI
1665517 1665519
UPC
0355150156207 0355150157303
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 ANDA202328 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/20mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (55150-156-20) / 20 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

55150-156-20 1 VIAL, SINGLE-USE in 1 CARTON (55150-156-20) / 20 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

levofloxacin (500 mg/20mL)

Linked Drug Pages (1)

Levofloxacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2a91fee4-6952-42e2-8326-c2d4233d11d3", "openfda": {"nui": ["N0000193223", "M0372253"], "upc": ["0355150156207", "0355150157303"], "unii": ["6GNT3Y5LMF"], "rxcui": ["1665517", "1665519"], "spl_set_id": ["4d400bf9-988f-42ec-93f1-e71a93a324b2"], "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": "1 VIAL, SINGLE-USE in 1 CARTON (55150-156-20)  / 20 mL in 1 VIAL, SINGLE-USE", "package_ndc": "55150-156-20", "marketing_start_date": "20130124"}], "brand_name": "Levofloxacin", "product_id": "55150-156_2a91fee4-6952-42e2-8326-c2d4233d11d3", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "product_ndc": "55150-156", "generic_name": "Levofloxacin", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "500 mg/20mL"}], "application_number": "ANDA202328", "marketing_category": "ANDA", "marketing_start_date": "20130124", "listing_expiration_date": "20261231"}