levofloxacin

Generic: levofloxacin

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler ani pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

levofloxacin 25 mg/mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-852
Product ID 70954-852_b548d9b8-70c9-41d4-8103-41568d50f561
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091678
Listing Expiration 2026-12-31
Marketing Start 2024-03-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954852
Hyphenated Format 70954-852

Supplemental Identifiers

RxCUI
477391
UPC
0370954852308 0370954852100
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 ANDA091678 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (70954-852-10)
  • 200 mL in 1 BOTTLE (70954-852-20)
  • 480 mL in 1 BOTTLE (70954-852-30)
source: ndc

Packages (3)

70954-852-10 100 mL in 1 BOTTLE (70954-852-10) 70954-852-20 200 mL in 1 BOTTLE (70954-852-20) 70954-852-30 480 mL in 1 BOTTLE (70954-852-30)

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": ["ORAL"], "spl_id": "b548d9b8-70c9-41d4-8103-41568d50f561", "openfda": {"nui": ["N0000193223", "M0372253"], "upc": ["0370954852308", "0370954852100"], "unii": ["6GNT3Y5LMF"], "rxcui": ["477391"], "spl_set_id": ["a894e40b-77e4-439b-b0f8-9a5cc7a1dd90"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (70954-852-10)", "package_ndc": "70954-852-10", "marketing_start_date": "20240326"}, {"sample": false, "description": "200 mL in 1 BOTTLE (70954-852-20)", "package_ndc": "70954-852-20", "marketing_start_date": "20240326"}, {"sample": false, "description": "480 mL in 1 BOTTLE (70954-852-30)", "package_ndc": "70954-852-30", "marketing_start_date": "20240326"}], "brand_name": "Levofloxacin", "product_id": "70954-852_b548d9b8-70c9-41d4-8103-41568d50f561", "dosage_form": "SOLUTION", "product_ndc": "70954-852", "generic_name": "Levofloxacin", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "25 mg/mL"}], "application_number": "ANDA091678", "marketing_category": "ANDA", "marketing_start_date": "20240326", "listing_expiration_date": "20261231"}