NDC 35356-923

Levofloxacin

Levofloxacin

Levofloxacin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Levofloxacin.

Product ID35356-923_44f5e7e3-3fbe-47c6-a500-012fb88dde7d
NDC35356-923
Product TypeHuman Prescription Drug
Proprietary NameLevofloxacin
Generic NameLevofloxacin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-06-20
Marketing CategoryANDA / ANDA
Application NumberANDA077438
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameLEVOFLOXACIN
Active Ingredient Strength500 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 35356-923-10

10 TABLET, FILM COATED in 1 BOTTLE (35356-923-10)
Marketing Start Date2011-06-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-923-21 [35356092321]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077438
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-20
Marketing End Date2018-12-31

NDC 35356-923-10 [35356092310]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077438
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-20
Marketing End Date2019-06-30

NDC 35356-923-07 [35356092307]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077438
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-20
Marketing End Date2018-12-31

NDC 35356-923-14 [35356092314]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077438
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-20
Marketing End Date2018-12-31

NDC 35356-923-20 [35356092320]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077438
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-20
Marketing End Date2018-12-31

Drug Details

Active Ingredients

IngredientStrength
LEVOFLOXACIN500 mg/1

OpenFDA Data

SPL SET ID:d6f22b14-a6c7-4d14-9a84-c67f5450fcb5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199885
  • 199884
  • NDC Crossover Matching brand name "Levofloxacin" or generic name "Levofloxacin"

    NDCBrand NameGeneric Name
    0121-0872LevofloxacinLevofloxacin
    0143-9315LevofloxacinLevofloxacin
    0143-9316LevofloxacinLevofloxacin
    0143-9317LevofloxacinLevofloxacin
    0143-9720LevofloxacinLevofloxacin
    0143-9721LevofloxacinLevofloxacin
    0143-9722LevofloxacinLevofloxacin
    0143-9775LevofloxacinLevofloxacin
    0143-9776LevofloxacinLevofloxacin
    0143-9777LevofloxacinLevofloxacin
    0409-0528LEVOFLOXACINLEVOFLOXACIN
    0527-1948LevofloxacinLevofloxacin
    0781-5790LevofloxacinLevofloxacin
    0781-5791LevofloxacinLevofloxacin
    0781-5792LevofloxacinLevofloxacin
    0904-6351LevofloxacinLevofloxacin
    0904-6352LevofloxacinLevofloxacin
    0904-6353LevofloxacinLevofloxacin
    10544-143LevofloxacinLevofloxacin
    10544-245LevofloxacinLevofloxacin
    10544-451levofloxacinlevofloxacin
    68071-1860LevofloxacinLevofloxacin
    68071-3089LevofloxacinLevofloxacin
    68071-3051LevofloxacinLevofloxacin
    68071-1932LevofloxacinLevofloxacin
    68071-3091LevofloxacinLevofloxacin
    68071-3093LevofloxacinLevofloxacin
    68071-3166LevofloxacinLevofloxacin
    68071-3218LevofloxacinLevofloxacin
    68071-4101LevofloxacinLevofloxacin
    68071-3271LevofloxacinLevofloxacin
    68071-3236LevofloxacinLevofloxacin
    68071-4422LevofloxacinLevofloxacin
    68071-4340LevofloxacinLevofloxacin
    68071-4547LevofloxacinLevofloxacin
    68071-4623LevofloxacinLevofloxacin
    68071-4726LevofloxacinLevofloxacin
    68071-4512LevofloxacinLevofloxacin
    68071-4738LevofloxacinLevofloxacin
    68084-481LevofloxacinLevofloxacin
    68084-483LevofloxacinLevofloxacin
    68084-482LevofloxacinLevofloxacin
    68180-240LevofloxacinLevofloxacin
    68180-242LevofloxacinLevofloxacin
    68180-241LevofloxacinLevofloxacin
    68382-017levofloxacinlevofloxacin
    68382-015levofloxacinlevofloxacin
    68382-016levofloxacinlevofloxacin
    68382-989levofloxacinlevofloxacin
    68788-6938LevofloxacinLevofloxacin

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