levofloxacin

Generic: levofloxacin

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

levofloxacin 500 mg/100mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9721
Product ID 0143-9721_27201c72-46ca-4507-8333-00e8ec582ba0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091375
Listing Expiration 2026-12-31
Marketing Start 2011-09-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439721
Hyphenated Format 0143-9721

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 ANDA091375 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/100mL
source: ndc
Packaging
  • 24 BAG in 1 CARTON (0143-9721-24) / 100 mL in 1 BAG (0143-9721-01)
source: ndc

Packages (1)

0143-9721-24 24 BAG in 1 CARTON (0143-9721-24) / 100 mL in 1 BAG (0143-9721-01)

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": "27201c72-46ca-4507-8333-00e8ec582ba0", "openfda": {"nui": ["N0000193223", "M0372253"], "unii": ["6GNT3Y5LMF"], "rxcui": ["1665497", "1665507", "1665515"], "spl_set_id": ["e680c759-16c5-4532-9c9c-f42c8c3df74a"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BAG in 1 CARTON (0143-9721-24)  / 100 mL in 1 BAG (0143-9721-01)", "package_ndc": "0143-9721-24", "marketing_start_date": "20110916"}], "brand_name": "Levofloxacin", "product_id": "0143-9721_27201c72-46ca-4507-8333-00e8ec582ba0", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "0143-9721", "generic_name": "Levofloxacin", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "500 mg/100mL"}], "application_number": "ANDA091375", "marketing_category": "ANDA", "marketing_start_date": "20110916", "listing_expiration_date": "20261231"}