levofloxacin

Generic: levofloxacin

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

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

levofloxacin 25 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-394
Product ID 68083-394_949f1c99-7067-450e-bc22-504f5aed0de9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205540
Listing Expiration 2026-12-31
Marketing Start 2020-04-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083394
Hyphenated Format 68083-394

Supplemental Identifiers

RxCUI
1665517 1665519
UPC
0368083395018
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 ANDA205540 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-394-01) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

68083-394-01 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-394-01) / 20 mL in 1 VIAL, SINGLE-DOSE

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": "949f1c99-7067-450e-bc22-504f5aed0de9", "openfda": {"nui": ["N0000193223", "M0372253"], "upc": ["0368083395018"], "unii": ["6GNT3Y5LMF"], "rxcui": ["1665517", "1665519"], "spl_set_id": ["ba69722b-d7f2-4519-8a63-9ee91294c499"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (68083-394-01)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68083-394-01", "marketing_start_date": "20200422"}], "brand_name": "LEVOFLOXACIN", "product_id": "68083-394_949f1c99-7067-450e-bc22-504f5aed0de9", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "68083-394", "generic_name": "LEVOFLOXACIN", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVOFLOXACIN", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "25 mg/mL"}], "application_number": "ANDA205540", "marketing_category": "ANDA", "marketing_start_date": "20200422", "listing_expiration_date": "20261231"}