levofloxacin

Generic: levofloxacin

Labeler: bpi labs llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler bpi labs llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

levofloxacin 15 mg/mL

Manufacturer
BPI LABS LLC

Identifiers & Regulatory

Product NDC 54288-140
Product ID 54288-140_4c9a6374-9e83-420d-bc29-20170bfbc6e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205600
Listing Expiration 2026-12-31
Marketing Start 2020-07-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54288140
Hyphenated Format 54288-140

Supplemental Identifiers

RxCUI
545118
UPC
0354288140010
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 ANDA205600 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 15 mg/mL
source: ndc
Packaging
  • 1 CARTON in 1 CARTON (54288-140-01) / 5 mL in 1 CARTON
source: ndc

Packages (1)

54288-140-01 1 CARTON in 1 CARTON (54288-140-01) / 5 mL in 1 CARTON

Ingredients (1)

levofloxacin (15 mg/mL)

Linked Drug Pages (1)

Levofloxacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "4c9a6374-9e83-420d-bc29-20170bfbc6e1", "openfda": {"nui": ["N0000193223", "M0372253"], "upc": ["0354288140010"], "unii": ["6GNT3Y5LMF"], "rxcui": ["545118"], "spl_set_id": ["b6d9740b-2f9d-4f1c-bc9b-4c2150b22f10"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["BPI LABS LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CARTON in 1 CARTON (54288-140-01)  / 5 mL in 1 CARTON", "package_ndc": "54288-140-01", "marketing_start_date": "20200713"}], "brand_name": "Levofloxacin", "product_id": "54288-140_4c9a6374-9e83-420d-bc29-20170bfbc6e1", "dosage_form": "SOLUTION/ DROPS", "product_ndc": "54288-140", "generic_name": "Levofloxacin", "labeler_name": "BPI LABS LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "15 mg/mL"}], "application_number": "ANDA205600", "marketing_category": "ANDA", "marketing_start_date": "20200713", "listing_expiration_date": "20261231"}