levofloxacin

Generic: levofloxacin

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler baxter healthcare corporation
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

levofloxacin 25 mg/mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 36000-045
Product ID 36000-045_3cbc7b81-fabf-4666-951c-76f19e4f3222
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091436
Listing Expiration 2026-12-31
Marketing Start 2013-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36000045
Hyphenated Format 36000-045

Supplemental Identifiers

RxCUI
1665497 1665507 1665515 1665517
UPC
0336000047241 0336000045018 0336000046244
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 ANDA091436 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 20 mL in 1 VIAL, SINGLE-USE (36000-045-01)
source: ndc

Packages (1)

36000-045-01 20 mL in 1 VIAL, SINGLE-USE (36000-045-01)

Ingredients (1)

levofloxacin (25 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": "3cbc7b81-fabf-4666-951c-76f19e4f3222", "openfda": {"nui": ["N0000193223", "M0372253"], "upc": ["0336000047241", "0336000045018", "0336000046244"], "unii": ["6GNT3Y5LMF"], "rxcui": ["1665497", "1665507", "1665515", "1665517"], "spl_set_id": ["70c87464-1806-480a-8ebd-3f02987ff436"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 mL in 1 VIAL, SINGLE-USE (36000-045-01)", "package_ndc": "36000-045-01", "marketing_start_date": "20130701"}], "brand_name": "Levofloxacin", "product_id": "36000-045_3cbc7b81-fabf-4666-951c-76f19e4f3222", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "36000-045", "generic_name": "levofloxacin", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "25 mg/mL"}], "application_number": "ANDA091436", "marketing_category": "ANDA", "marketing_start_date": "20130701", "listing_expiration_date": "20261231"}