levofloxacin

Generic: levofloxacin

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

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levofloxacin 250 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-536
Product ID 65862-536_00620274-6cae-4cb8-bd5d-8f80732ae3ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201043
Listing Expiration 2026-12-31
Marketing Start 2011-06-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862536
Hyphenated Format 65862-536

Supplemental Identifiers

RxCUI
199884 199885 311296
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 ANDA201043 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (65862-536-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 50 TABLET, FILM COATED in 1 BOTTLE (65862-536-50)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-536-99)
source: ndc

Packages (3)

65862-536-10 10 BLISTER PACK in 1 CARTON (65862-536-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 65862-536-50 50 TABLET, FILM COATED in 1 BOTTLE (65862-536-50) 65862-536-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-536-99)

Ingredients (1)

levofloxacin (250 mg/1)

Linked Drug Pages (1)

Levofloxacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "00620274-6cae-4cb8-bd5d-8f80732ae3ca", "openfda": {"nui": ["N0000193223", "M0372253"], "unii": ["6GNT3Y5LMF"], "rxcui": ["199884", "199885", "311296"], "spl_set_id": ["529ac72c-c4a0-4001-8cf9-b94f5bf7265c"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-536-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-536-10", "marketing_start_date": "20110620"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (65862-536-50)", "package_ndc": "65862-536-50", "marketing_start_date": "20110620"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-536-99)", "package_ndc": "65862-536-99", "marketing_start_date": "20110620"}], "brand_name": "Levofloxacin", "product_id": "65862-536_00620274-6cae-4cb8-bd5d-8f80732ae3ca", "dosage_form": "TABLET, FILM COATED", "product_ndc": "65862-536", "generic_name": "Levofloxacin", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "250 mg/1"}], "application_number": "ANDA201043", "marketing_category": "ANDA", "marketing_start_date": "20110620", "listing_expiration_date": "20261231"}