levofloxacin

Generic: levofloxacin

Labeler: advagen pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler advagen pharma limited
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

levofloxacin 5 mg/mL

Manufacturer
Advagen Pharma Limited

Identifiers & Regulatory

Product NDC 72888-142
Product ID 72888-142_2ffa08e2-0405-47bb-e063-6294a90a4fe0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078282
Listing Expiration 2026-12-31
Marketing Start 2022-02-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72888142
Hyphenated Format 72888-142

Supplemental Identifiers

RxCUI
314080
UPC
0372888142227
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 ANDA078282 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (72888-142-22) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

72888-142-22 1 BOTTLE in 1 CARTON (72888-142-22) / 5 mL in 1 BOTTLE

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": ["OPHTHALMIC"], "spl_id": "2ffa08e2-0405-47bb-e063-6294a90a4fe0", "openfda": {"nui": ["N0000193223", "M0372253"], "upc": ["0372888142227"], "unii": ["6GNT3Y5LMF"], "rxcui": ["314080"], "spl_set_id": ["f2eb9444-333d-4b05-8cf3-2e6690a2bf99"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Advagen Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (72888-142-22)  / 5 mL in 1 BOTTLE", "package_ndc": "72888-142-22", "marketing_start_date": "20220222"}], "brand_name": "LEVOFLOXACIN", "product_id": "72888-142_2ffa08e2-0405-47bb-e063-6294a90a4fe0", "dosage_form": "SOLUTION", "product_ndc": "72888-142", "generic_name": "LEVOFLOXACIN", "labeler_name": "Advagen Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVOFLOXACIN", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "5 mg/mL"}], "application_number": "ANDA078282", "marketing_category": "ANDA", "marketing_start_date": "20220222", "listing_expiration_date": "20261231"}