levofloxacin

Generic: levofloxacin

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levofloxacin 500 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-438
Product ID 63187-438_42b9c689-6cdb-4667-ae4e-98cef35d1f8c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200839
Listing Expiration 2026-12-31
Marketing Start 2012-03-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187438
Hyphenated Format 63187-438

Supplemental Identifiers

RxCUI
199885
UPC
0363187438104
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 ANDA200839 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 3 TABLET, FILM COATED in 1 BOTTLE (63187-438-03)
  • 5 TABLET, FILM COATED in 1 BOTTLE (63187-438-05)
  • 7 TABLET, FILM COATED in 1 BLISTER PACK (63187-438-07)
  • 10 TABLET, FILM COATED in 1 BLISTER PACK (63187-438-10)
  • 14 TABLET, FILM COATED in 1 BOTTLE (63187-438-14)
  • 30 TABLET, FILM COATED in 1 BOTTLE (63187-438-30)
source: ndc

Packages (6)

63187-438-03 3 TABLET, FILM COATED in 1 BOTTLE (63187-438-03) 63187-438-05 5 TABLET, FILM COATED in 1 BOTTLE (63187-438-05) 63187-438-07 7 TABLET, FILM COATED in 1 BLISTER PACK (63187-438-07) 63187-438-10 10 TABLET, FILM COATED in 1 BLISTER PACK (63187-438-10) 63187-438-14 14 TABLET, FILM COATED in 1 BOTTLE (63187-438-14) 63187-438-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-438-30)

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": "42b9c689-6cdb-4667-ae4e-98cef35d1f8c", "openfda": {"nui": ["N0000193223", "M0372253"], "upc": ["0363187438104"], "unii": ["6GNT3Y5LMF"], "rxcui": ["199885"], "spl_set_id": ["2cb16f61-390f-4365-9c42-b21d87e469e0"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET, FILM COATED in 1 BOTTLE (63187-438-03)", "package_ndc": "63187-438-03", "marketing_start_date": "20210519"}, {"sample": false, "description": "5 TABLET, FILM COATED in 1 BOTTLE (63187-438-05)", "package_ndc": "63187-438-05", "marketing_start_date": "20190101"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BLISTER PACK (63187-438-07)", "package_ndc": "63187-438-07", "marketing_start_date": "20190101"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BLISTER PACK (63187-438-10)", "package_ndc": "63187-438-10", "marketing_start_date": "20190101"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (63187-438-14)", "package_ndc": "63187-438-14", "marketing_start_date": "20190101"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63187-438-30)", "package_ndc": "63187-438-30", "marketing_start_date": "20190101"}], "brand_name": "Levofloxacin", "product_id": "63187-438_42b9c689-6cdb-4667-ae4e-98cef35d1f8c", "dosage_form": "TABLET, FILM COATED", "product_ndc": "63187-438", "generic_name": "Levofloxacin", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "500 mg/1"}], "application_number": "ANDA200839", "marketing_category": "ANDA", "marketing_start_date": "20120322", "listing_expiration_date": "20261231"}