levofloxacin

Generic: levofloxacin

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levofloxacin 500 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-457
Product ID 43063-457_2c25d091-922a-7459-e063-6294a90a535f
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 43063457
Hyphenated Format 43063-457

Supplemental Identifiers

RxCUI
199885
UPC
0343063457108
UNII
6GNT3Y5LMF
NUI
N0000193223 M0372253

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
  • 500 mg/1
source: ndc
Packaging
  • 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-02)
  • 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-03)
  • 5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-05)
  • 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-07)
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-10)
  • 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-14)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-20)
source: ndc

Packages (7)

43063-457-02 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-02) 43063-457-03 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-03) 43063-457-05 5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-05) 43063-457-07 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-07) 43063-457-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-10) 43063-457-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-14) 43063-457-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-20)

Ingredients (1)

levofloxacin (500 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": "2c25d091-922a-7459-e063-6294a90a535f", "openfda": {"nui": ["N0000193223", "M0372253"], "upc": ["0343063457108"], "unii": ["6GNT3Y5LMF"], "rxcui": ["199885"], "spl_set_id": ["a5ae33ad-4703-4cb2-8618-6439c906be99"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-02)", "package_ndc": "43063-457-02", "marketing_start_date": "20120925"}, {"sample": false, "description": "3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-03)", "package_ndc": "43063-457-03", "marketing_start_date": "20120925"}, {"sample": false, "description": "5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-05)", "package_ndc": "43063-457-05", "marketing_start_date": "20120925"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-07)", "package_ndc": "43063-457-07", "marketing_start_date": "20120925"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-10)", "package_ndc": "43063-457-10", "marketing_start_date": "20120925"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-14)", "package_ndc": "43063-457-14", "marketing_start_date": "20210401"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-20)", "package_ndc": "43063-457-20", "marketing_start_date": "20221102"}], "brand_name": "Levofloxacin", "product_id": "43063-457_2c25d091-922a-7459-e063-6294a90a535f", "dosage_form": "TABLET, FILM COATED", "product_ndc": "43063-457", "generic_name": "Levofloxacin", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "500 mg/1"}], "application_number": "ANDA201043", "marketing_category": "ANDA", "marketing_start_date": "20110620", "listing_expiration_date": "20261231"}