levofloxacin

Generic: levofloxacin

Labeler: dr. reddy's laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler dr. reddy's laboratories limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levofloxacin 250 mg/1

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-279
Product ID 55111-279_c51f53eb-2f01-93dc-e7e6-695b20b639ce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076710
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 55111279
Hyphenated Format 55111-279

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 ANDA076710 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (55111-279-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (55111-279-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (55111-279-30)
  • 50 TABLET, FILM COATED in 1 BOTTLE (55111-279-50)
  • 10 BLISTER PACK in 1 CARTON (55111-279-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-279-79)
source: ndc

Packages (5)

55111-279-01 100 TABLET, FILM COATED in 1 BOTTLE (55111-279-01) 55111-279-05 500 TABLET, FILM COATED in 1 BOTTLE (55111-279-05) 55111-279-30 30 TABLET, FILM COATED in 1 BOTTLE (55111-279-30) 55111-279-50 50 TABLET, FILM COATED in 1 BOTTLE (55111-279-50) 55111-279-78 10 BLISTER PACK in 1 CARTON (55111-279-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-279-79)

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": "c51f53eb-2f01-93dc-e7e6-695b20b639ce", "openfda": {"nui": ["N0000193223", "M0372253"], "unii": ["6GNT3Y5LMF"], "rxcui": ["199884", "199885", "311296"], "spl_set_id": ["9b59428a-a23a-b2d9-982f-98f8a1ed381f"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (55111-279-01)", "package_ndc": "55111-279-01", "marketing_start_date": "20110620"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (55111-279-05)", "package_ndc": "55111-279-05", "marketing_start_date": "20110620"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (55111-279-30)", "package_ndc": "55111-279-30", "marketing_start_date": "20110620"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (55111-279-50)", "package_ndc": "55111-279-50", "marketing_start_date": "20110620"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-279-78)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-279-79)", "package_ndc": "55111-279-78", "marketing_start_date": "20110620"}], "brand_name": "Levofloxacin", "product_id": "55111-279_c51f53eb-2f01-93dc-e7e6-695b20b639ce", "dosage_form": "TABLET, FILM COATED", "product_ndc": "55111-279", "generic_name": "Levofloxacin", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "250 mg/1"}], "application_number": "ANDA076710", "marketing_category": "ANDA", "marketing_start_date": "20110620", "listing_expiration_date": "20261231"}